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U.S. Department of Health and Human Services

MedSun: Newsletter #54, November 2010

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Newsletter #54, November 2010

Articles

Medtronic Octopus Nuvo Tissue Stabilizer: Class I Recall

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Firm Press Release

There is the potential that a component of this device could fracture during use, which could have serious implications for the patient. Healthcare facilities should immediately discontinue use of the device and return all unused Octopus Nuvo Tissue Stabilizer devices to Medtronic.

Additional Information:

FDA Classifies Previous Field Action of Medtronic Surgical Device as Class I Recall. Recall -- Firm Press Release. October 29, 2010.
http://www.fda.gov/Safety/Recalls/ucm231855.htm

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Huber Needles: Recall - Risk of Coring

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class I Recall of certain Huber needles that were determined by FDA testing to produce cores when inserted into ports. Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core travelling through blood vessels into the patient’s lungs. Clinicians should immediately discontinue use of the recalled products. If you must use the kit, consider using an alternative, unaffected non-coring needle if possible.

For more information about FDA’s safety investigation of Non-Coring (Huber) Needles, please visit the website provided under Additional Information below.

Additional Information:

FDA MedWatch Safety Alert. Huber Needles: Recall - Risk of Coring. October 15, 2010.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm229068.htm

Safety Investigation of Non-Coring (Huber) Needles: Updated October 25, 2010. FDA Medical Device Safety.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm198766.htm

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Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility

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FDA MedWatch Safety Alert

Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. Consumers who have 5ml fill in 6 cc saline pre-filled syringes manufactured by Excelsior Medical should immediately discontinue using these syringes and return them to the point of purchase.

Additional Information:

FDA MedWatch Safety Alert. Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility. October 15, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229781.htm

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CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy

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FDA MedWatch Safety Alert

Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.

Additional Information:

FDA MedWatch Safety Alert. CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy. October 15, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229767.htm

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New Technology and Health Care Costs - The Case of Robot-Assisted Surgery

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New England Journal of Medicine

Technological innovation in health care is an important driver of cost growth. Doctors and patients often embrace new modes of treatment before their merits and weaknesses are fully understood. These technologies can lead to increases in costs, either because they are simply more expensive than previous treatments or because their introduction leads to an expansion in the types and numbers of patients treated. These patterns as they apply to the case of robot-assisted surgery are examined.

Additional Information:

New England Journal of Medicine. New Technology and Health Care Costs — The Case of Robot-Assisted Surgery. August 19, 2010.
http://www.nejm.org/doi/pdf/10.1056/NEJMp1006602

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LabNet

Compressed Gas Cylinder Safety

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Lab Manager Magazine

What follows here is a condensed set of basic guidelines applicable to all gas cylinders. Taking the time to develop and implement a compressed gas safety program for your research or production facility will go a long way toward preventing accidents and potential tragedy. Most fixes and corrections are low cost and easily installed and maintained. Compared to the costs associated with the alternatives, it is hard to argue against a good compressed gas safety program.

Additional Information:

Lab Manager Magazine. Compressed Gas Cylinder Safety. September 2010.
http://www.labmanager.com/stips.asp?ID=137

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HeartNet

Guidant Vitality HE Implantable Cardioverter Defibrillator: Class II Recall

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FDA Recalls

Exposure to a magnet may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs. This prevents delivery of programmed tachytherapy, and use of the Patient Triggered Monitor feature.

MedSun has received reports with this device. To read the event, please see the link provided in Additional Information below.

Additional Information:

FDA Recalls. Guidant Vitality HE Implantable Cardioverter Defibrillator: Class II Recall. October 7, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94150

MedSun report. March 3, 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2DK%3F%27%5F%5C%20%0A

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Guidant, Contak Renewal CRT: Class II Recall

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FDA Recalls

Exposure to a magnet may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs. This prevents delivery of programmed tachy therapy, and use of the Patient Triggered Monitor feature.

MedSun has received reports with this device. To read the event, please see the link provided in Additional Information below.

Additional Information:

FDA Recalls. Guidant, Contak Renewal CRT: Class II Recall. October 7, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94148

MedSun Report. April 2, 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2DK%3E%27%5FX%20%0A

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Philips IntelliVue MP2 patient monitor recall: Class II Recall

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FDA Recalls

Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment. The following MedSun-reported event occurred in the Emergency Room (ER) and is relevant to HeartNet clinical areas.

MedSun has received reports with this device. To read the event, please see the link provided in Additional Information below.

Additional Information:

FDA Recalls. Philips IntelliVue MP2 patient monitor recall: Class II Recall. September 29, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=94173&CREATE_DT=2010-09-29

MedSun Report. August 30, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5DW%3B%27%5FH%20%0A&CFID=50094208&CFTOKEN=99b71ffe191c9bc9-AB37E

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HomeNet

Featured HomeNet Report of Interest

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In this featured HomeNet report of interest, an infusion pump was connected to a home care patient with the intent to deliver penicillin at a rate of 19.6 ml/hour. The drug was delivered at a rate of 40.5 ml/hour instead. The home care nurse assumed that the rate had been set by the out-patient pharmacy; however, the pharmacy technician who sent the pump to the patient's home doesn't normally assume this responsibility.

While the incident was the result of process mistakes rather than a device-related problem, this report is important because it validates the added complexities that arise as it relates to device set-up upon patient discharge to the home setting.

HomeNet is particularly interested in learning about problems with medical devices used in the home as a function of the unique use environment, such as:

•Concerns with device instruction for use and labeling
•Issues with patient and caregiver training or
•Issues with device appropriateness and compatibility in the home setting.

If you become aware of problems with devices indicated for use in the home or with devices that are typically used in the home setting, with devices that fail or do not perform as intended, or those that represent a potential for harm, please report these events through your MedSun representative, if you are a member of MedSun or HomeNet., or through your hospital’s reporting policy.

If you are not affiliated with a hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related adverse events a model for patient safety.

Please see the MedSun report provided under Additional Information below.

Additional Information:

MedSun Report. September 29, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5DW7%26%2FH%20%0A

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KidNet

Resectoscopes for Infants and Babies: Medical Device Safety Tips

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FDA Medical Device Safety

This safety tip originally appeared in October's MedSun newsletter but the KidNet team would like to reiterate its importance for pediatric patient populations.

During cystoscopy and incision of a ureterocele in a 2-month old, the insulation slipped off the sheath and slid over the tip of the catheter exposing the hook electrode. Fortunately, the 2-month old was not injured. It was discovered that improper sequence of assembling the resectoscope was associated with this situation. This event reminds us of the importance to follow the proper sequence of steps outlined in the manufacturer’s user manuals when assembling resectoscopes for endoscopy procedures. For more information, please see the full Medical Device Safety Tip under Additional Information below.

Additional Information:

FDA Medical Device Safety. Resectoscopes for Infants and Babies - Medical Device Safety Tips. September 24, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm227105.htm

October 2010 MedSun Newsletter reference. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=53#2

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Discussions with Healthcare Providers

Thioglycollate Culture Media and Tissue Samples: MedSun Small Sample Survey Summary

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Survey Topic: Thioglycollate Culture Media and Tissue Samples
Year Conducted: 2009


Background
Effective treatment of an infection hinges on reliable initial readings of Gram Stains that are confirmed by the results of the cultures. Since the culture can take days or even weeks to grow out the offending organism the initial Gram Stain reading is pivotal to directing the initiation of treatment. The tools and resources utilized in the Gram Stain and culture process can have great impact on the results which then may impact a patient’s treatment. The culture media, the cell and tissue transporter, grinders, etc., must not interfere or alter the tissue or cells for the Gram Stain and the culture. Non-viable organisms appear to be viable in the Gram Stain but do not grow out in the culture, hence creating a discrepancy between the initial reading and final culture results.

FDA received adverse events about thioglycollate media possibly containing high non-viable organism counts that may affect the reliability of results. A survey of nine laboratory professionals was conducted to better understand experiences with the use of thioglycollate media with gram stain procedures. The information that follows is a summary of the interviews.

Summary
All respondents grind their tissue specimens to perform Gram staining or other microbiological staining. The decision on whether to grind and mince the specimen depended on the size of the sample and how the tissue was going to be prepared. Most hospitals used sterile saline as a liquid culture medium when grinding and mincing tissue. All performed direct Gram stains on ground tissue samples. And in most cases the direct Gram stain results were reported directly back to the requesting physician.

Generally, the respondents have also experienced discrepant culture and direct smear results. Most believed those results were due to lab errors, previous antibiotic treatment, or nonviable organisms from various types of cultures, including thioglycollate (thio), or transport media. Most of the respondents re-examined the smears and/or repeated cultures when there was a discrepancy. Some also went back to the original sterile specimen and re-inoculated the plate, re-read the gram stains, or worked with infection control staff.

Many of the respondents also had some kind of experience with nonviable organisms seen on Gram stains. Possible reasons for those high nonviable counts included, problems with the stain or slides, and nonviable organisms in transport media, and previous antibiotic treatment. When erroneous results did occur, several respondents switched from thio based on literature recommendations and potential for contamination. To prevent misinterpretation of smear results, the respondents used quality control checks, read literature for best practices, and investigated nonviable or other unexpected organisms. Even though the respondents had experienced discrepant results at some point most were unaware of a patient ever having been treated based on a false positive Gram stain due to the presence of nonviable organisms.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.



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Small Sample Survey Questions


1. Can you tell us about the method you use for performing gram stains on collected specimens?
a. Do you grind and mince tissue/biopsy in your laboratory?

2. What type of microbiological culture media do you use to grind and mince the tissue?

3. Do you perform staining on the ground tissue sample?
• If so, what type of staining method do you perform on the tissue specimens?

4. Do you report direct stain results to the physician or clinician who requested the diagnostic procedure?

5. Have you experienced high nonviable counts with your direct smear results?
• If so, were there any changes you observed with the media?
• Have you been able to determine possible reasons for the high nonviable counts?

6. Have you experienced any other types of erroneous results with nonviable counts in other media associated with direct Gram stains or other direct microbiological results?
• If so, what kind of results did you find and how frequently have you seen these erroneous results?

7. What actions have you taken when you experienced erroneous results?
• Have you made the manufacturer aware?
• If so, what was the manufacturer’s response?

8. Have you experienced a situation where a patient was treated based on a false-positive Gram stain result?

9. How do you communicate information about the possibility of false-positive Gram stain results to staff?

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Dynamic Stabilization Systems: MedSun Small Sample Survey Summary

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Survey Topic: Dynamic Stabilization Systems
Year Conducted: 2009


Background
An estimated 200,000 spinal fusion procedures are performed each year in the United States with a projected increase due to an aging population. As these procedures have become more common, FDA wanted to better understand how surgeons are using pedicle screw based posterior spinal stabilization systems that include “dynamic” or motion-preserving features. FDA has received over 100 adverse event reports involving these systems from a variety of manufacturers. Also, there was a recall in 2008 by Medtronic for the Agile model due to device cable failure. A survey was conducted to gather information from orthopedic surgeons about their use of these systems and the clinical outcomes. Five surveys from five different facilities were completed; two by phone interviews and three by written questionnaires. The questions included the types of systems used, indications for treatment and the experience and clinical outcomes with these devices.

Summary
The most commonly used dynamic stabilization systems by the respondents are the Zimmer Spine Dynesys and DTO, the Medtronic Sofamor Danek - CD Horizon PEEK Rods, and the Depuy Spine –Viper and Expedium PEEK Rods systems. Experience with these devices ranges from six months to more than four years. The most common systems are usually used in multi-level procedures, ranging from 1-4 levels. Since their initial use with these devices, most respondents have completed about ten procedures, one has performed an estimated 300.

All of the respondents stated that they treat the lumbar level of the spine. Most performed fusion procedures with half of the respondents also performing non-fusion and hybrid procedures. The most commonly treated indications are degenerative disc disease followed by spinal stenosis, spondylolisthesis, and failed spinal fusion.

Other pedicle screw based dynamic stabilization systems are used less frequently including the Medtronic Sofamor Danek Agile after the recall. The reasons for infrequent use include cost, less experience with the device, and different indications. About half said that the way in which they use the devices has changed over time, including the adoption of a more hybrid construct.

Adverse events with these systems were reported infrequently. One reason given was that it was too soon after the procedure for problems to show up. Recurrence of symptoms was noted in about 10% of one respondent’s patients but was attributed to the patients’ history. Another reported an adverse event involving junctional disc disease but said it was unrelated to the device’s failure. The respondents stated that adverse events most commonly occurred anywhere from 1-6 years after implantation.

Types of secondary surgical interventions performed included device removal and conversion to fusion with a rigid rod system, addition of supplemental fixation, additional decompression, and device revision. One respondent said during device revision, the same device was replaced and an interbody spacer was added. These secondary surgical interventions usually occurred 4-6 years after implantation.

Clinical outcomes for fusion status, pain/function scores, and neurological status ranged from good to excellent. Outcomes based on the intended uses of fusion, non-fusion, and hybrid also ranged from good to excellent. For indications of degenerative disc disease, spinal stenosis, and spondylolisthesis the ratings were good. The clinical outcome for treatment of one level of the spine was excellent while the outcome for treatment of two levels or higher was good. None of the respondents have evaluated radiographs at this point in time to obtain range of motion data.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.


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Small Sample Survey Questions

Please check the answers below (double-click the box if using electronically). If necessary, fill in the appropriate dialog (click on the yellow box and then start typing).

1. Please identify the one system below that you most commonly use and the approximate number of procedures you have performed since you began use.
Manufacturer – Device):
0 Zimmer Spine - Dynesys and DTO
0 Medtronic Sofamor Danek - Agile
0 Synthes - NFix II (also known as NFlex, NHance, or NGarde)
0 Scient’x - Isobar
0 Medtronic Sofamor Danek - CD Horizon PEEK Rods
0 Depuy Spine - Viper and Expedium PEEK Rods
0 Paradigm Spine - DSS
0 Biospine - BioFlex
0 Globus Medical - AccuFlex Rods
0 Vertiflex - Dynabolt
0 Other:

Approximate number of procedures performed with this device since initial use?

2. Are there other pedicle screw based “dynamic stabilization” systems you use less often?
0 Yes
0 No

If yes, please list them and explain why they are used less commonly (i.e. experienced adverse events, appeared less favorable in the literature or at a conference)?

NOTE: The remaining questions refer to the one system you use most often.

3. With the device that you use most often, do you perform (check all that apply):
0 Single level procedures
0 Multi-level procedures - up to how many levels?
0 N/A

4. What spinal levels do you treat (check all that apply)?
0 Lumbar
0 Thoracic
0 Cervical
0 N/A

5. Do you perform (check all that apply):
0 Fusion procedures
0 Non-fusion procedures
0 Hybrid procedures (fusion at one level and non-fusion at an adjacent level)
0 N/A

6. What indications are you treating most often (check all that apply)?
0 Degenerative disc disease
0 Kyphosis
0 Failed Spinal Fusion
0 Spondylolisthesis
0 Spinal Stenosis
0 N/A
0 Other (Please List):

7. How long have you been using the device?
0 Less than 6 months
0 1-2 years
0 2-3 years
0 3-4 years
0 4+ years
0 N/A

8. Has the way in which you use the device changed over time?
0 Yes
0 No
0 N/A
If yes, how and why?

9. What types of adverse events have you observed and how many of each type have you observed?

10. How long after implantation do these adverse events most commonly occur?
0 0-6 months
0 7-12 months
0 1-2 years
0 2-4 years
0 4-6 years
0 6+ years
0 N/A

11. In your opinion, what do you think contributed to these events?

12. What types of secondary surgical interventions have you performed (check all that apply)?
0 Device removal and conversion to fusion with rigid rod system
0 Addition of supplemental fixation
0 Additional decompression
0 N/A
0 Device revision (Briefly explain the revision surgery performed and any replacement devices that were implanted)
0 Other:

13. How long after implantation do these secondary surgical interventions most commonly occur?
0 0-6 months
0 7-12 months
0 1-2 years
0 2-4 years
0 4-6 years
0 6+ years
0 N/A

For questions 14-17 below, 5=Excellent, 4=Good, 3=Fair, 2=Poor, 1=Very Poor.

14. How would you rate the clinical outcomes in reference to the following:

Pain/Function Scores:
1.0 2.0 3.0 4.0 5.0 N/A

Fusion Status (If fusion was intended):
1.0 2.0 3.0 4.0 5.0 N/A

Neurological Status:
1.0 2.0 3.0 4.0 5.0 N/A

15. How would you rate the outcomes based on the following intended uses:

Fusion:
1.0 2.0 3.0 4.0 5.0 N/A

Non-Fusion:
1.0 2.0 3.0 4.0 5.0 N/A

Hybrid:
1.0 2.0 3.0 4.0 5.0 N/A

16. How would you rate the outcomes based on the indications being treated:

Degenerative Disc Disease:
1.0 2.0 3.0 4.0 5.0 N/A

Kyphosis
1.0 2.0 3.0 4.0 5.0 N/A

Failed Spinal Fusion
1.0 2.0 3.0 4.0 5.0 N/A

Spondylolisthesis:
1.0 2.0 3.0 4.0 5.0 N/A

Spinal Stenosis:
1.0 2.0 3.0 4.0 5.0 N/A

17. How would you rate the outcomes based on the number of levels treated:

1 level:
1.0 2.0 3.0 4.0 5.0 N/A

2 levels:
1.0 2.0 3.0 4.0 5.0 N/A

3+ levels:
1.0 2.0 3.0 4.0 5.0 N/A

18. Have you evaluated any radiographs to look at range of motion data? If yes, would you be willing to provide any available de-identified data?
0 Yes
0 No


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Health Information Systems: MedSun Small Sample Survey Summary

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Survey Topic: Health Information Systems
Year Conducted: 2009


Background
Computerized patient care systems are used by many health care facilities. Food and Drug Administration, Center for Devices and Radiological Health (CDRH) is interested in learning more about the experiences of hospital staff using these patient care systems, especially on the patient care side involving Computerized Physician Order Entry (CPOE). In order to understand the issues that hospitals have with these systems before, during and after implementation, a survey was conducted with health care professionals from five facilities. The focus of the survey was on the functionality of the systems and the topics discussed were the impact of the system, usability, user satisfaction, and problem resolution with systems that facilities have implemented. Another goal of the survey was to better understand any potential issues involving health information systems. Nine staff members representing several hospital departments were interviewed and the information that follows is a summary of the interviews.

Summary
Generally, the respondents had mixed feelings about their health information system’s usability. However, users did say that the impact of CPOE systems have changed workflow dramatically for the better. Documentation quality has improved and one respondent believed their medication errors have been reduced by 30%.

User dislikes include pop-up features because they can cause alert fatigue. Other dislikes include implementing complicated order sets and the fact that multiple applications have a different look and feel, even within the same vendor’s products. User likes include the way the system delivers decision support. They also liked the ability to use admission order sets, like medication adjudication, and have automated this process for patients’ discharge from the hospital.

Training for users ranged from no training for some staff to 24 hours for IT staff. Training time also depended on the role of the employee. Physicians generally received the least training, followed by nurses and other non-physicians. IT staff and other super-users received the most training. Also, there was usually more training for big software releases.

In general, experiences with system reliability have been good. Unplanned downtime is rare and normally very short with an estimated uptime close to 100%. When forced to return to paper orders during downtime they see more errors, including, incomplete orders, missing medication routes, and incorrect abbreviations. Staff realize how much safer CPOE is, versus a paper system. Experience with recovery from outages was also good.

Most respondents were unaware of any adverse event reports with a CPOE system. Most reports of system malfunction were related to human error. Types of other problems included those with system defaults and how patient data interfaces with the application.

Future plans for respondents’ health information systems included adding bar-coding of medications, expansion to the emergency room, and incorporating infusion pumps in a pharmacy management system. Respondents are also working to assure that their electronic medical records (EMR) are going to adhere to the evolving standards for the exchange of data with other facilities.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.


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Small Sample Survey Questions

{Legend: questions asked to Clinicians = XX; IT staff = IT; Management = M}

1. Impact/Usability

Does the system meet the expectations of users (i.e.- does it support the workflows of clinicians)
•Does the system functionality match your requirements? (XX, IT, M)
•How is the system compatible with other systems/software/IT infrastructure? (IT)
•How well the system is compatible with your original processes/workflows? (XX, IT, M)
User likes and dislikes (Clinical Decisions)
•List top three areas of system that you like and dislike? (XX, IT, M)
•During installation and configuration does the clinician have the ability to override system constraints such as dose amount, frequency, etc(XX, IT)

2. Training

User training received on how to use of the system, before and after system deployment
•How much training was provided for use of the CPOE system (XX, IT, M)
•How would you rate the quality of the training received. On a scale of 1- 5 (with 5 being the highest) (XX, IT, M)
Training of IT staff and implementation teams related to deployment of the system
•Who installed and implemented your system? (i.e.- the hospital IT department vs. the manufacturer vs. 3rd-party consultant vs. other) (IT, M)
•Does the manufacturer verify/validate that the system is installed/implemented correctly? (IT, M)
•Does the manufacturer provide appropriate support/training to install/implement if done by hospital or hospital representatives? (IT, M)
•When the manufacturer installs an update/patch, do they validate/verify that the system continues to function as intended? (IT, M)
•Does the hospital or manufacturer validate/verify that other vendor products in use at the hospital (integrated or interfaced) are not adversely affected when their CPOE device is installed/implemented? (IT, M)

3. Reliability

How reliable are these systems (System reliability)
•Have you experienced any system outages and at what frequency? (XX, IT, M)
oDaily, weekly, monthly, yearly
•How long does these outages last? (XX, IT, M)
•Is recovery from outages stable or unstable? (?, IT, M)
What are the procedures in place during any system downtime, power outages, etc (System maintenance/upgrades)
•Is there a controlled policy in place for system upgrades/updates/maintenance software releases? (IT, M)
•What is the frequency of the updates? (XX, IT, M)
•What is the stability of the system after software maintenance is completed? (XX, IT, M)
ounstable, relatively unstable, no difference, relatively stable, stable
•Is there a validation procedure for updates before deploying the changes on the production system (on actual data)? (IT, M)
Disaster recovery/emergency plan
•How often does your data have to be retrieved from backup? (IT, M)
•What was the quality of system stability after data restoration from backup? (XX, IT, M)
•What policies and procedures are in place in event of long outages? (XX, IT, M)

4. Problem resolution

Categories/Types of problems encountered
•Have you encountered problems with your CPOE systems? (XX, IT, M)
•If so, what kind of problems have you faced? (XX, IT, M)
•Have you had any adverse events associated with these problems? (XX, IT, M)
•Have you reported any Medical Device Reports (MDRs) associated with these problems? (XX, IT, M)
Procedures for reporting problems encountered and improvement requests
•How long does it take to resolve these problems (XX, IT, M)
•Does your facility have the ability to request feature enhancements? (XX, IT, M)
•What procedures are followed feature enhancements request and implementation by the vendor? (XX, IT, M)

5. Other

Management oversight
•Is there an Audit process for workflow, data integrity and adherence to standards of the hospital (XX, IT, M)
•What are typical findings (most prevalent) (XX, IT, M)


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Surgical Hernia Mesh: MedSun Small Sample Survey Summary

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Survey Topic: Surgical Hernia Mesh
Year Conducted: 2009


Background
There have been several recalls and warning letters sent over the last 5 years to distributors, hospital administrators, and Chief Surgeons to let them know about device defects with surgical mesh. In October 2008, FDA updated its safety information on mesh used in hernia repair. Although the vast majority of adverse event reports received are related to recalled meshes, FDA continues to see reports discussing adverse reactions to mesh including, but not limited to, adhesions, infection, perforation, and injuries to nearby organs, nerves or blood vessels.

In an effort to obtain more information about the use of surgical mesh and clinical outcomes, a survey was conducted with nine clinicians that included general surgeons and operating room personnel. The information that follows is a summary of the interviews.

Summary
When selecting a mesh for hernia repair, respondents said that the size of the hernia and the type of repair needed were the most important factors. About half of the respondents did avoid certain meshes for various reasons such as Dualmesh® or Gore-Tex® because of an increased infection rate and in-growth problems, and Vicryl™ mesh because it doesn’t dissolve. The Prefix® Plug for “virgin” hernias was avoided because it doesn’t cover the area well and can shrink into a meshoma.

Respondents stated they removed mesh infrequently, about 1 out of every 100 procedures, and added that complications were rare. The most common complications warranting removal of the mesh were infection, recurrent hernia, and a fibrotic reaction. Most had not seen complications with one type of mesh more often than with other types. Chronic pain was deemed a significant complication which was mostly attributed to excessive sutures around the mesh, the surgical technique used in inguinal repairs, and fibroblasts growing into the interstices of the mesh.

FDA is pursuing additional avenues to obtain information about the use of mesh in hernia repair.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.


****************************************************
Small Sample Survey Questions

Surgeon Practice

•In your practice, what percentage of cases involve hernia repair? Approximately how many hernia operations do you perform per year?
•What types of hernias do you typically see and repair (i.e. inguinal, ventral)?
•In these cases, how often do you use mesh for the repair? How do you make the decision to use mesh? What would you say is the breakdown of mesh/non-mesh hernia repairs that you perform?
•What operative procedure(s) do you perform using mesh to repair hernias? (i.e., laparoscopic, open procedure?)

Mesh material and design

•What types of mesh do you use most often? For example, polypropylene; PTFE meshes, biologic, others?
•Do you use different designs such as 1-dimensional and 3-dimensional mesh?
•Is the type of mesh you use most often pre-cut or non-pre cut?

Implantation

•With the type of mesh that you use most often, what patient characteristics play a role in mesh selection and use? (i.e., diabetic, obese, male, female)
•What types of mesh do you usually avoid using? And, for what reasons?
•How do you secure mesh? Have you had any problems using the fixation devices?

Explantation

•How often do you have to remove mesh? What types of mesh have you removed most often? And why?
•What are the most common complications you see that warrant removal of the implanted mesh? How often do these complications occur, i.e., 1 out of 10 surgeries, 1 out of 20 surgeries, etc.?
•Have you seen complications with one type of mesh more often than other types?
•Have you seen a difference in complications with pre-cut mesh vs. non pre-cut mesh?
•Do you ever see any complications during the explantation of a particular mesh product?
•Do you ever see adverse events, such as, tissue irritation that may be associated with modified mesh, or have needed to do a revision because of irritated tissue?

Device Performance and Experience

•In your opinion, what types of mesh have resulted in better patient outcomes?
•In your opinion, are patient outcomes dependent upon specific patient characteristics, such as the use of a particular type of mesh in a particular type of patient?
•What do you usually tell your patients about the use of mesh in hernia surgery?
•Prior to using mesh in your patients for hernia repair, how did you learn about mesh repair (i.e. did you receive training during your residency, did you take a course, did you read about the procedure, etc)?
•Do you think the training you received was sufficient?
•How could the training have been improved?

Device Labeling

As you know, FDA clearance is required for marketing a medical device within the US. With respect to surgical mesh, what is your expectation regarding the level of evidence that served as the basis for FDA’s clearance/approval?

FDA’s review of medical devices involves the evaluation of medical device labeling. To what extent have you used or referred to the product labeling that you have used for operations involving mesh?
•If you have seen the labeling, did it meet your needs?
•If you have not seen the labeling, what is your expectation regarding the types of information that should be included in the labeling?

Patient Informed Consent

FDA has heard from patient groups that informed consent regarding the use of mesh products for hernia repair is variable.
•What do you think could be done to better inform patients of the risks/benefits associated with hernia repair using mesh products?
•Do you have any standard consent form you use for these procedures? Do you think that the FDA can play a role in this?

In addition, FDA has also heard that more attention from the perspective of patient informed consent, mesh product manufacturer labeling, and surgeon training should be given to providing more information regarding salvage or removal of implanted mesh used in hernia repair.
•What are your thoughts on this?
•To what extent do you think that FDA and/or professional societies serve to help research and disseminate information about how implanted mesh may be salvaged or retrieved?

Recalls

•How do you typically become aware of recalls? How does your hospital track recalls?



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Large Volume Infusion Pumps: MedSun Small Sample Survey Summary

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Survey Topic: Large Volume Infusion Pumps
Year Conducted: 2009


Background
Large volume infusion pumps are an integral part of patient care. They provide safer administration of fluids and medication than in the past. The variety of pumps available is expanding all the time. With the numerous recalls of large volume infusion pumps recently, the FDA wanted to learn more about how future recalls might affect hospitals and their quality of care. To meet this need, a special study or survey was conducted with nine healthcare professionals from nine MedSun facilities. The information that follows is a summary of the interviews.

Summary
The Hospira Plum, Baxter Colleague, Sigma Spectrum, and the Alaris were cited as the primary brands of infusion pumps used by respondents. They also use large volume infusion pumps in high acuity areas, including the ICU, ER, NICU, and OR. The average number of pumps used per patient in these areas varied greatly depending on the hospital, the type of pump, and patient needs.

In the case of pump failures, all respondents had extra pumps on critical care units. The number of additional back up pumps varied based on patient census. Other options in case of pump failure included borrowing pumps from other units or hospitals, and rentals. When asked about the estimated time it took to replace a pump the response was immediately when pumps were available on the unit, and 5-45 minutes if obtained from central supply. Once a replacement pump is found, all said it would take 5 to 10 minutes to re-initiate infusion therapy.

All respondents conduct product trials before changing out their pumps. Under normal circumstances, this process takes anywhere from 3-18 months. Training time for clinical staff on new pumps varied from 2 weeks to 3-4 months.

Overall, respondents described a permanent recall and product support discontinuation of their primary brand of infusion pumps as a complicated scenario. None have a plan in place that would address this while continuing to provide care for patients. Most stated they could use intravenous (IV) flow regulators or count drips until they could replace infusion pumps, but they all considered these methods to have major safety and training issues. However, most felt they could meet the challenge, especially with help from the vendors. They said the replacement process of infusion pumps would be easier and executed more quickly if they had vendor information and products readily available.

Respondents also said that if multi-channel pumps were no longer available it would create a different set of challenges to care for patients needing multiple therapies. Those challenges include an increase in plugged-in devices, space requirements, and an increase in the number of devices sent to the biomedical department and central supply. It was suggested that FDA could assist manufacturer actions by providing comparisons of pumps and encouraging or requiring vendors to respond to hospitals in a timely fashion.


Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.


********************************************************
Small Sample Survey Questions

1. How many large volume infusion pumps does your hospital have in use? (own or rent)

2. How many do you have available for back up? (own or rent)

3. What types and brands are they? And, are your pumps multi-channel, single channel or both?
a. For example, there are several types of infusion pumps on the market now with various module or channels such as,
i. Baxter has (Colleague, Flo-gard, etc.),
ii. Cardinal Health Alaris has (Medley, Signature Edition, Signature Gold, Gemini, etc.),
iii. Hospira has (Omniflow, Plum, Symbiq, etc.)

4. In your hospital, what areas do you consider to be high acuity areas? Are pumps used all the time in these areas? (e.g., ICU, ER, OR, oncology, other specialty areas, etc.)
a. In the type of clinical setting(s) you mention, what is the average number of patients that are being cared for at one time?
b. Of these patients, what is the average number of pumps used on a high acuity patient?

5. When a pump fails:
a. What procedures are in place for critical care areas and general units to replace pumps that fail?
b. On average, how long does it take you to find a replacement pump?
c. On average, how long does it take you to initiate or re-initiate infusion therapy with a patient?

6. Can you please describe for us what you use when a patient needs multiple infusions and...
a. You don’t have the pumps you need.
b. What do you do if you have the pumps you need but the space required to set up multiple pumps at the bedside is not available? Do you ever find you have to move other beds to have access to outlets and additional space?

7. What other types of pumps does your hospital have and how many of each?
a. Elastomeric?
b. Peristaltic?
c. Syringe?

8. What is the process your facility uses to determine when to change out (purchase new/different pumps) the infusion pumps from your hospital? For example, do you have a (new products) committee, or use a specific purchasing process or decision tree, etc?) If you have a committee, what staff are on the committee?
a. Do you conduct product trials before changing out the pumps?
b. How long does that process usually take? Given normal circumstances how long would it take to replace your infusion pump supply?

9. If your primary brand of infusion pumps was permanently recalled with product support discontinued and instructions given to remove the devices from use:
a. How would you address this scenario while continuing to provide care to your patients? (Include additional training, other expenses, etc.)
b. What would make your replacement process easier and faster to execute?
c. How could FDA and the manufacturer facilitate the actions you take in your hospital?

10. If your multi-channel pumps were no longer available, what actions would you take to meet the requirements for patients needing multiple therapies?
a. If you replaced your multi-channel channel pumps with single channel pumps, (for example 3 single channel pumps in place of one triple channel pump), could you accommodate the:
*Increased space requirement for storage (i.e. extra I.V. poles, outlets in storage locations)?
*Increased number of devices that need to be plugged in except during transport?
*Increased space requirements and number of outlets needed for the pumps in the OR, ER, etc.
*Increased number of devices that your central supply and biomed departments would need to process?

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Point of Care Devices and Erroneous Potassium Results: MedSun Small Sample Survey Summary

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Survey Topic: Point of Care Devices and Erroneous Potassium Results
Year Conducted: 2009


Background
Point of care (POC) testing is utilized increasingly on patient care units, especially critical care areas, due to its convenience and accessibility to clinicians. The quick and readily available results from POC devices enable clinicians to respond with treatment faster than ever before. Frequently, clinical decisions are made based upon results from POC devices, which makes it imperative to ensure their reliability and validity. Nine people from nine facilities were surveyed after FDA received several reports of issues involving POC testing of potassium levels; specifically regarding the hemolysis of samples which may produce erroneous results. The goal of the surveys was to better understand any on-going or potential issues involving the POC testing of potassium levels. The information that follows is a summary of the interviews.

Summary
Generally, the respondents had positive experiences with POC testing of potassium. The i-Stat™ POC analyzer, Chem8 model and the Gem Premier™ 2000, 3000, and 4000 were the most commonly used devices. None of the respondents experienced problems with erroneous potassium results due to hemolysis. However, a few did mention they had seen hemolysis with samples and therefore discarded it and obtained a new sample. None of the respondents had knowledge of, or reported incidents of patients being treated for an incorrect potassium reading due to hemolysis.

It was the opinion of most participants that erroneous potassium results due to hemolysis do occur. However, they said it is hard to quantify how often it happens due to lack of reporting about potassium errors. Poor sampling technique was cited as the most common reason for erroneous potassium results. Hemolysis was also cited as a potential reason for erroneous potassium results with POC testing, especially if the sample was set down for too long before processing.

But the respondents generally thought that hemolysis of samples was not a problem for their hospital. Each respondent’s hospital has procedures in place to reduce the potential for hemolysis, such as drawing the sample with a syringe and then placing it in the vacutainer. All respondents also had protocols or standard procedures for handling erroneous potassium results and all stated that no patients received any treatments due to an erroneous result. However, the protocols discussed were not specifically for errors due to hemolysis.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.


***********************************************************
Small Sample Survey Questions

1. What brand(s) of Point-of-Care analyzer do you use at your hospital?

2. Have you experienced problems with erroneous potassium results?
a. In general, how often does it occur?
b. What are some reasons or causes for the erroneous results?
c. Can you confirm the erroneous results are due to hemolysis or do you suspect that hemolysis is the cause of the problem?
d. What percentage of time do you think the problem is due to hemolysis?

3. In situations where the erroneous results were due to hemolysis, how did you detect the problem?

4. What actions did you take to resolve the problem?

5. Do you have a specific protocol for handling erroneous results due to hemolysis?

6. Have you experienced a situation where a patient was treated for an incorrect high or low potassium reading? Was there harm to the patient in either of the above two situations?

7. Have your hospital ever changed Point-of-Care analyzers due to the problem with hemolyzed samples? If so, what brand did you switch to?

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Home Hemodialysis Systems: MedSun Small Sample Survey Summary

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Survey Topic: Home Hemodialysis Systems
Year Conducted: 2010


Background
As the home care sector continues to expand, so will the use of advanced medical device technology in the home environment. In order for the Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) to ensure that medical devices are used safely and effectively in the home setting, the purpose of this survey was to learn about device issues faced by professional home care providers, as well as those issues potentially encountered by informal caregivers who use Home Hemodialysis (HHD). Since dialysis treatments at home can be self-initiated, managed or used with the assistance of a trained caregiver, often a family member, CDRH is interested to learn about users’ experiences with these systems.

Surveys were conducted with eight health care professionals to gather information about home care providers’ and users’ experiences with hemodialysis systems used in the home environment. Questions focused on the following topics:
*Device performance and experience
*Prescription and Discharge
*Training and Labeling
*Water treatment compatibility
*Patient outcome

Summary
Overall, respondents have had good experiences with patients receiving HHD. Fresenius and NxStage systems were cited as the most commonly used systems. NxStage system users have more favorable opinions, especially because they don’t require a specialized water system and are small and portable. While respondents seemed very happy with the materials and support provided by the manufacturer(s), it is interesting to note that additional materials are often developed (sometimes by the patient) to supplement what the manufacturer provides. Respondents feel that the more recent material is better than what was provided in the past.

Prescription, discharge planning and training tends to vary as a function of the facility’s procedures. For the most part, a physician – commonly a nephrologist – prescribes the patient with HHD and then the dialysis nurses will further assess the patient and their home environment to determine if they are a good candidate for the treatment. Patient training will then ensue, often times in the dialysis clinic or center by nurse educators. Majority of the respondents also require a family caregiver be trained along with the dialysis patient. Training tends to be very individualized to best cater to the patient and patient caregiver’s abilities and needs. Depending on the individual and on the system, training duration may vary, anywhere from 1.5 to 8 weeks. One respondent notes that most patients demonstrated understanding in 3-4 weeks; by the 4th or 5th week, patients were able to do their own treatment unobserved. Whereas the survey questions primarily focus on how the facility trains patients and caregivers, one respondent commented favorably on the training provided to their nursing staff by Fresenius and NxStage.

Respondents feel it is important that patients have HHD as an option because it provides them with more independence and a better quality of life. Majority of the respondents advocate home care as opposed to receiving care in a center because it is one-on-one treatment. Respondents generally feel that the patient’s commitment, motivation and support play a vital role in their success. In fact, some respondents encourage making use of support networks so that patients and caregivers can learn from one another.

Small scale surveys are one of many tools the Agency uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Because these surveys utilize a small sample size that is not statistically derived, the results provide only qualitative and not quantitative results. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program, and will continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes a possible public health problem may be emerging from the results of a survey, it will combine those results with data gained from the other sources and may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

FDA will work with the manufacturers and health care professional organizations to make important information known about medical devices to the clinical community.


***********************************************************
Small Sample Survey Questions

Device performance and experience

o Have you or your patients experienced difficulty using these systems in the home?
o What home hemodialysis systems do you currently use, or are most familiar with? Manufacturer? Brand? Type?
o Which systems have resulted in better patient outcomes?

Prescription

o If these systems are being used in the home, how are they typically prescribed?
o Are patients monitored by home care nurses or aides when these devices are used in the home setting?
o What is involved in the discharge planning with the caregiver or patient when they go home from the hospital with this system?
o What do you usually tell your patients about using these systems?
o Do patients express concern if using these systems themselves in the home?

Training and Labeling

o Have patients and their caregivers been trained?
o If so, by whom?
o Does the training take place in the hospital before discharge or when the patient is already at home?
o Is training mandatory for patients and caregivers who use the device in their home?
o If so, please describe the training. For example, was it video-based, hands-on, demo? What materials were provided?
o Do these systems have labels or other written instructions for use? If so, are the labels written for a lay audience?
o In your opinion, what challenges have you observed with caregivers’ ability to understand and follow device instructions? With the patients’ ability (if they self administer the treatment)?
o What do you think could be done to better inform patients of the risks/benefits associated with using these systems, especially in the home setting?

Water treatment compatibility

o Which water treatment systems are used with the hemodialysis systems you currently use, or are familiar with?
o Do these typically come with the hemodialysis system, or are they purchased separately?
o If purchased separately, have you or your patients experienced compatibility issues?
o Have you seen complications with the hemodialysis system versus the water treatment system?

Patient outcome

o In your opinion, are patient outcomes dependent upon specific patient characteristics, i.e. patient age, capabilities, caregiver or provider support?
o In your opinion, do you think that a patient could perform hemodialysis at home by themselves?


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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period August 1 through August 31 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device:
Type: Absorbent, Carbon-dioxide
Manufacturer: GE Healthcare, Vital Signs, Inc
Brand: Sodasorb
Model#: M1173312
Lot#: C201-P133-08

Problem:
Our hospital had used a product from GE named "Medisorb" for a long period of time, with no issues or concerns. This product is a CO2 absorbent used in all of our anesthesia machines. In early July it was noted that our facility started receiving a different product from GE. Initially we returned the product thinking it was an error in ordering. We again received and returned the different product. Upon questioning, GE stated they had discontinued making Medisorb and that they had sent a letter which our Materials Management department did not receive. We have MULTIPLE concerns with the replacement product: 1. The lid to the canisters containing the sodasorb are not grooved in any way, they just sit on the base which allows the lid to "pop off" easily letting the toxic pellets into the operating rooms. 2. The top edge of the base portion of the canister has cracked in several instances which allows pressure leaks and EXCESSIVE amount of dust in the OR's. In the past 2 weeks our anesthesia machines have had to be repaired/cleaned twice due to excessive dust. The dust causes machine leaks, gets everywhere, on the machine seals and in the past it has even made it through the machine to the patient circuit. 3. The replacement product is not labeled with a product name. The canister just states Prepackaged cartridge, Original, Disposable. There also appear to be 2 lot numbers on the packaging with neither of them being located where the canister says "lot". One is printed in small letters running horizontally on canister...the other is around the upper lip of canister. 4. It is felt by anesthesiology staff that the Sodasorb heats to a much higher temperature than the original Medisorb and appears to need changing with higher frequency. It is also taking staff a large amount of time troubleshooting issues, safely removing excess dust out of the product without compacting the granules in an effort to maintain the utmost CO2 absorption. 5. We have been told other facilities have started voicing similar complaints and GE has been in contact with the manufacturer and it has been suggested that a movement for change may be starting. Our facility will NOT be using this product. We feel it is unsafe to our patients, our staff and our equipment. Both canisters are from same lot number. We are now trialing an alternate product from a different vendor.
======================
Manufacturer response for CO2 Absorbent Canister
======================
Multiple emails and meetings with product rep.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Maquet, Inc
Brand: Servo-i
Lollipop Icon

Problem:
Ventilator kept alarming. Unable to solve problem. Patient ventilator was found to be without circuit compliance turned on. Vent settings had to be increased for ventilator support since the compliance was turned off. We had to change the circuit and the expiratory cassette in order for the machine to pass the circuit compliance check. Investigation revealed that the Servo vent will discontinue the tubing compensation automatically if the circuit test fails. The only way to tell that it is off is the absence of gold stripes around the volume and a small "c" appears. It was very hard to see and read. It is also not described in the manual.
======================
Health Professional's Impression
======================
Poor design. The warning that the circuit compliance is off is not clearly stated in the manual. It is also very hard to read. A small gold/ amber line. The smaller "c" is on the third screen and not easily seen.
======================
Manufacturer response for Ventilator, Servo
======================
They are looking into our recommendations.

Device:
Type: Condenser, Heat And Moisture (Artificial Nose)
Manufacturer: Ventlab Corp
Brand: Heat Moisture Exchanger
Model: FH603008

Problem:
Our facility learned our usual Heat Moisture Exchanger (HME) filters were on backorder and was offered a compatible placement product from the manufacturer. The only difference was to be the addition of a sampling port but other than that all measurements etc should have been the same. These filters are used on every adult general anesthetic procedure at our facility. Replacement items were received at our facility on a previous date. A few days later, it was reported to our office the anesthesia tech attempted to place one of the new replacement filters onto the anesthesia machine and the item would not fit. Pictures were taken and multiple personnel witnessed the device not fitting onto the flow sensors of the anesthesia machine. Another filter was obtained and fit VERY snuggly onto the flow sensor but was able to be used safely. While troubleshooting this issue another anesthesia tech reported having trouble the day before with one replacement filter not fitting but threw it away and did not notify anyone at the time. It has been determined the replacement filters either fit appropriately, fit very tightly or don't fit at all. No injury to patient, just delay in set up, and concern with work around in general. All anesthesia techs have been notified to watch for this concern and report issues to our office until our original product is available. Of note: An additional concern has been identified. The plastic packaging on the device does not state a lot number or expiration date. The cardboard box which the product is shipped in contains the only mention of a lot number, etc. These cardboard shipping boxes are not allowed in our inventory areas. Because of this, we are not able to include a lot number with this report and now have no way of knowing the lot numbers our facility received.
======================
Health Professional's Impression
======================
Does not fit appropriately. Measurements appear to be slightly different than what product information states.
======================
Manufacturer response for Heat Moisture Exchanger (HME) with filter and sampling Port, Tri-Anim
======================
Mfg. Rep met with our Materials Mgmt. staff to address concerns and find acceptable solution. Rep requested we save any involved items for return.


CARDIOVASCULAR

Device:
Type: Catheter, Ultrasound, Intravascular
Manufacturer: Volcano Corporation
Brand: Eagle Eye Gold

Problem:
Threading the Eagle Eye IVUS (intravascular ultrasound) catheter over the interventional wire (BMW) and the wire would not thread through the exit port. Cleaned wire multiple times - tried to thread IVUS catheter twice.


Device:
Type: Electrode Pad, Electrocardiograph, Adult
Manufacturer: ConMed Corporation
Brand: Ecg Backpad
Model#: 01-3130
Lot #: 1006041 2012-06
Cat #: 01-3130
Lollipop Icon

Problem:
A child with asthma and renovascular hypertension was admitted to the PICU for monitoring following aorto-renal bypass surgery lasting 2.5 hours. A note in the chart two days later indicated: "Patient was up and out of bed for the first time. Burn mark noted to the back from cardiac lead stickers from surgery. Practitioner notified; assessment was area in lower thoracic region has bubbling and some skin peeling noted." On first assessment, the practitioner thought that the area appeared to be either a reaction to or a skin burn from a bovie pad that was likely placed during the OR case. The area was approximately 8 inches by 10 inches in size; had blisters, then spread before skin sloughed off. The burn was treated with Meplex and healed. It was determined that there was no pooling of skin prep solution under the patient. There was no skin prep prior to placement of the backpad. This issue was investigated for the possibility of a radiation burn due to left renal angiogram with angioplasty 3 weeks prior. The patient was in interventional radiology (IR) from about 0840-1025. The radiation dose recorded by the IR staff for this renal angiogram was 164 uGy or 0.0164 rad. It is generally believed that no skin changes are seen at doses less than 200 rad. It is unknown if the warming blanket, coagulator pad/ESU could have contributed to the event. The patient was supine during surgery.


Device:
Type: Electrophysiology Recording System
Manufacturer: St. Jude Medical
Brand: Ep Medsystems
Model#: EP Med Software Version 4.1.0

Problem:
The electrophysiology (EP) four channel stimulator is connected to the EP Med recorder. During a ventricular tachycardia (VT) ablation, while pace-mapping, the EP Med froze and would not respond to the "HALT pacing" button on the keyboard. Pacing continued at rate of 250 ms (240 beats per minute) instead of stopping after three to four beats. While the EP Med system lagged, it continued to pace for four seconds, sixteen beats. The patient went into rapid, hemodynamically unstable ventricular tachycardia and required 200 joule external cardioversion. VT induced intentionally as a normal course of the procedure, but this specific episode was unintentional. The procedure continued as planned and the patient suffered no harm. This software "freeze" prevented the EP Med system from communicating with the EP-4 stimulator, so pacing could not be stopped using the usual "HALT" pacing keyboard button until the computer lag resolved (4 seconds later). The prolonged rapid pacing in the ventricle resulted in a VT that was accelerated from the patient's baseline VT and caused hemodynamic collapse.


Device:
Type: Hyperthermia Unit, Forced Air
Manufacturer: Arizant Healthcare
Brand: Bair Hugger
Model#: 505
Other #: Underbody Pad
Lollipop Icon

Problem:
Large rectangular erosion of back status post epidermal loss. Based on localized, rectangular morphology this is most consistent with an extrinsic thermal, ultraviolet radiation, or chemical factor that has led to epidermal necrosis and subsequent blister formation.
======================
Health Professional's Impression
======================
First report was that the burn was caused by an Arizant Bair Hugger
======================
Manufacturer response for Hyperthermia Unit, Forced Air, Bair Hugger (per the site reporter):
======================
Issue is around using these units on pediatric patients. In conversations with Arizant rep, they indicated that this unit should not be used on high. I asked if there was any labeling that they had to indicate this and they do not. The concern is that the unit could reach 56 degrees centigrade without shutting off.

The particular piece of equipment that was used on the patient was not identified. All units in surgery were evaluated and determined to meet manufacturer specifications.

My immediate concern is that these units have a maximum setting of 43 Degrees C. If the unit has a fault and continues to heat, it can reach 56 Degrees C. I believe this temperature is unsafe for infant/pediatric patients. There needs to be labeling by the manufacturer warning of using higher temperatures, or specific devices manufactured for this type of patient.


Device:
Type: Monitor, Blood Pressure, Transducer, Non-indwelling; Transducer, Blood-pressure, Extravascular
Manufacturer: Edwards Lifesciences
Brand: Pressure Monitoring Kit
Lot #: 58807471
Cat #: PXVK0831

Problem:
Anesthesia technician reports while getting ready for a CABG procedure she opened a new Pressure Monitoring kit and noted the high pressure tubing was disconnected from one of the transducer ports. Our office confirmed this is a connection site which should not come apart. This product was provided to us from the manufacturer as a replacement for a custom pressure monitoring kit which happens to be on backorder. We previously reported the same exact issue with our original product (PXVX225). Our anesthesia technician was told by the product rep that both broken kits had a "glue station" issue where one of the tubes going into a transducer did not adhere. The technician reports she replaced the damaged item with a new one from a different lot with no further issues or concerns.
======================
Health Professional's Impression
======================
It was broken upon opening.

See device image:
Photograph of Edwards Life Sciences Pressure Monitoring Kit, which shows the high pressure tubing disconnected from one of the transducer ports


GENERAL HOSPITAL

Device:
Type: Catheter, Implanted, Port
Manufacturer: Bard Access Systems
Brand: Powerport
Model#: Ref 1809600
Lot #: REUDO409

Problem:
After the port was inserted, the nurse was not able to aspirate blood. However, the port flushed with ease. 500ml of saline was infused and a cardiac drug was given. After infusing a portion of a unit of blood, the patient had swelling surrounding the port site. The transfusion was discontinued at that site and started in a peripheral site.
======================
Health Professional's Impression
======================
It was removed by the same surgeon. IV dye was used and it showed extravasation so another catheter was inserted. The surgeon was hopeful to only having to manipulate the catheter and possibly saving it and not having to reopen the pocket.



Device:
Type: Catheter, Picc
Manufacturer: Bard Access Systems Inc.
Brand: Sherlock Power Picc Double Lumen
Model#: 5 Fr. Double Lumen Basic Tray with MI
Lot #: REUA0530 and REUE 0882

Problem:
After placement of the Sherlock Power PICC, the chest x-ray showed a small wire in the pulmonary artery. This was removed by the Interventional Radiologist. The small wire was at the top of the stylet wire, which had separated from the rest of the wire. The tip has a small magnet added to it for tracking of the progression of the catheter as it is being inserted with the Bard Sherlock technology.
======================
Health Professional's Impression
======================
The stylet in the PICC magnet tip separated from the rest of the wire and embolized to the pulmonary artery requiring Interventional Radiology to place a line into the femoral artery and pull the piece of the stylet out.


Device:
Type: Fluid Warmer And Infuser
Manufacturer: Smiths Medical
Brand: Level 1
Model#: H250
Other #: 8000024

Problem:
Level 1 Infuser would not infuse blood into patient that had been involved in auto-pedestrian accident. Upon inspection by Biomed, it was noted that the gauge was broken and tubing on back of gauge had broken off. Different infuser brought to unit to continue treatment.
Patient had multiple rib fractures and scapular fracture, developed hemothorax requiring attempts at surgical decompression and repair but patient expired in operating room.
======================
Health Professional's Impression
======================
Blood could not be infused into patient - had to seek alternate device.

See device images:

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.

Photograph of Smiths Medical infuser gauge that was broken.  Tubing on back of gauge had broken off.



Device:
Type: Light, Phototherapy
Manufacturer: GE Healthcare
Brand: Giraffe Pt Spot Light
Model#: 100-240VAC 50/60 Hz
Other #: Biomed Tag# 18677
Lollipop Icon

Problem:
The overhead fiber optic bililight made a loud popping sound and began to emit smoke. The light was turned off and unplugged from the outlet. It felt hot to the touch. The equipment was immediately tagged, removed, and sent to Biomed. Preventative maintenance was done two months ago. There was no harm to the patient. In addition, I was informed that it was the bulb inside of the light that went bad and actually popped and broke inside the light. It then emitted a burning odor, which may have been caused by the shards of glass inside. The glass did not reach the patient or staff. The light bulb was metered at 416 hours and typically is changed out at 500 hours. We have not had any other incidences of bulbs breaking. BioMed is reviewing their records as far as the age and number of the devices we have, and if we have any replacement parts in the device. Awaiting BioMed follow up.


Device:
Type: Needle, Hypodermic, Single Lumen
Manufacturer: Smiths Medical
Brand: Jelco Needle-pro
Cat #: 4292
Other #: 25g x 1" needle. Needle hub color is orange. A case is 8 boxes of 100.
Lollipop Icon

Problem:
Medical assistant (MA) was giving a minor patient a varicella vaccination into upper extremity and needle broke off at hub where the white part connects needle to bevel. Medication squirted all over patient, MA and counter. A new vaccination was drawn up and administered. The staff has been having issues with this brand of needles in that they come out of the person’s subcutaneous tissue, bent as well.


Device:
Type: Phototherapy, Neonatal
Manufacturer: GE Healthcare
Brand: Giraffe Spot Pt Light
Model#: 6600-0845-800
Lollipop Icon

Problem:
While doing repairs on an infant warmer, the clinical engineer noticed the Giraffe Spot PT light hanging on the side of the warmer had a brown area on the lens cover. After further investigation, the brown area appeared to be burned. The technician then went to the Newborn ICU and observed several other units with the same problem. Some of the covers observed were actually melted. It was noted during this investigation that several of these PT Spot lights are mounted to the sides of the open Ohio Infant warmer systems. The gooseneck of the lamps is swung so the lens is actually under the heating element of the warmer. This is causing the burn and melted areas on the lens covers. Clinical Engineering suggested to the department that these lights not be placed under the heating element. This practice has a potential for starting a fire.

Clinical Engineering suggested the goose neck on the light be moved so the lens cover is to the side of the warmer case and not below the heating element. These lens covers are made of plastic. The heat emitted from the warmer's heating element could cause burning and melting of the plastic.


Device:
Type: Urine Specimen Collection Cup
Manufacturer: BD
Brand: Bd Vacutainer
Model#: 364956

Problem:
There have been two occasions where the urine specimen cups had a sharp edge which resulted in the fingers or hands of the individual collecting the specimen to be nicked (skin tear) resulting in exposure to the patient's urine. Appropriate exposure protocol was initiated for the health care providers.


Device:
Type: Warmer, Infant Radiant
Manufacturer: Drager Medical
Brand: Babytherm
Model#: 8004
Lollipop Icon

Problem:
While in patient use, six of the nine Drager Babytherm 8004 infant warmers have had the hot side fuse holder burn up.


Device:
Type: Iv Tubing Set
Manufacturer: Carefusion
Brand: Alaris
Other#: 606-238-100

Problem:
The IV tubing formed a balloon. This has happened before.

Device:
Type: Iv Tubing, Vial Access
Manufacturer: ICU Medical
Brand: Genie
Lot#: 86-765-2A

Problem:
Three Genie Vial Access devices failed in IV Therapy clinic, all were the same lot number. One fell apart after being snapped in to vial. One had no spike on it - so could not be used, and one leaked 3-4cc of Etoposide out of the vial and on to the gloves of the person handling it and on to the mat in the hood.
======================
Health Professional's Impression
======================
Genie vial access devices are breaking, leaking and are coming out of the packaging with no spike.
======================
Manufacturer response for IV access device, Genie Vial access device
======================
No response from manufacturer


NEUROLOGY

Device:
Type: Motor, Drill, Pneumatic
Manufacturer: THE ANSPACH EFFORT, INC
Brand: Black Max
Lollipop Icon

Problem:
The exhaust gas line, which removes gas away from the pneumatic drill, ruptured during a craniotomy creating a loud bang in the OR. Several staff members complained of hearing loss immediately following the rupture. Injury is expected to be temporary.
======================
Health Professional's Impression
======================
High pressure build up in the exhaust hose. The hose did not have a pressure relief valve.
======================
Manufacturer response per the site reporter
======================
Anspach released a manufacturers letter in the spring of last year stating that they were upgrading to a new style hose that has a built in pressure relief valve. The manufacturer stated that new hoses and those needing repair would be fitted with this valve. There were no upgrades to older models unless they were in disrepair.


OBSTETRICS/GYNECOLOGY

Device:
Type: Disposable Vacuum Assist Cup
Manufacturer: OB Scientific
Brand: Gentlevac Vacuum Assist Cup
Lot #: 015031-1-1

Problem:
Gentle Vac was used to assist in the birth of the baby. This is not the standard or even second often used vacuum assist. The suction end has a plastic piece (disk) that should be removed prior to use. It looks differently than the other device's plastic pieces that need to be removed and not easily differentiated by staff. There is print on the removable disc stating to remove prior to use, but it is just raised print in the same color as the disk and difficult to see by staff. A picture is available (below). In this case the disk was not removed prior to use and when the baby was born the disk was on her head and left minor scratches.
======================
Health Professional's Impression
======================
The disk that should have been removed was not because it wasn't obvious based on the way it is designed and the less than easy to read print.

See device image:
Photograph of the Disposable Vacuum Assist Cup

RADIOLOGY

Device:
Type: Ct Scanner
Manufacturer: General Electric
Brand: Light Speed Vct
Model#: Light Speed VCT

Problem:
There was a repair necessary on the CT scanner. Originally, the engineer thought the tube was blown and, after it was replaced, he realized it was not the tube, but the tank. A tank was ordered and repairs were completed. Scans were performed for the following two days. Began noticing image quality issues on the second day. Contacted GE - engineer came in the next day and ran a QA scan. Found air bubbles in the oil line which was causing images to look as if there was pathology.

The engineer removed air bubbles from oil and ran another test scan, then turned the scanner back over to the department for clinical use.


Device:
Type: X-ray System, C-arm, Portable
Manufacturer: GE OEC Medical Systems

Problem:
Post procedure when archiving images to PACS/DR to be read, images or studies are discovered missing at which time Biomedical Engineering is notified. The procedural outcome has not been affected by this GE OEC recall.





~~~~~~~~
Special Note:
Lollipop Icon The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.





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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Thermal Regulating Systems

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Per the code of federal regulations, "A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature (1)."

Over the past year, MedSun has received 28 adverse event reports associated with thermal regulating systems manufactured by the following firms: Arizant, Inc., Cincinnati Sub-Zero, Inc., Gaymar Industries, Inc., Medivance, Inc., and Smiths Medical ASD, Inc. The reports were submitted by 17 hospitals between September 2009 and September 2010.

The reported device problems were:
Leaking (e.g. leaking of the water circulating blanket, which is connected to the controller unit) – 4 reports
Temperature issues (such as accidentally programming the controller unit to an unintended setting) – 2 reports
Electrical or overheating issues (with the power cord or other component on the controller unit). – 5 reports
Disconnection (of an accessory from the controller unit) – 1 report
Patient worn garment too tight – 1 report
No device problem noted – 15 reports

None of the reports involved a patient death. The patient outcomes listed below were reported.
• Skin blistering – 10 reports
• Skin reddening – 8 reports
• Decreased heart rate – 1 report
• No harm to patient – 9 reports

Of the reports that listed patient age, 6 had a patient age listed as less than 21 years and 15 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 9 reports involved female patients and a total of 12 reports involved male patients.

These MedSun reports, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems. These MedSun reports may, or may not, be involved in the recall(s) listed.

Over the past year, FDA follow-up with the manufacturer resulted in three recalls and two warning letters issued (details of the warning letters can be found online at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219661.htm and http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm217747.htm ).

The following 3 recall(s), are noted to be associated with thermal regulating systems.



Recall 1: Class 2 Recall - BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 (2)

Date Posted: March 16, 2010
Recall Number: Z-0895-2010
Product: Electri-Cord Manufacturing Corporation
(312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair
Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature
Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Code Information: Part number 502221 Model 90024
Recalling Firm/Manufacturer: Arizant Inc; 10393 W 70th St; Eden Prairie, Minnesota 55344
Reason for Recall: Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger
Action: An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.
Quantity in Commerce: Total distributed for all devices: 84,537 US, 7,380 OUS.
Distribution: Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.


Recall 2: Class 2 Recall - WARM AIR WARMING UNIT (3)

Date Posted: February 04, 2010
Recall Number: Z-0781-2010
Product: FilteredFlo Cardiac Blanket. The
device is used to distribute heated air around a patient (for patient
warming).
Code Information: Product # 82542; Catalog # 542; Lot #: 07279, 07280,
07424 & 08813.
Recalling Firm/Manufacturer: Cincinnati Sub-Zero Products Inc; 2011 Mosteller Rd Cincinnati, Ohio 45241-1528
Reason for Recall: Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.
Action: On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.
Quantity in Commerce: 1,095 Blankets
Distribution: Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.


Recall 3: Class 2 Recall - WarmAir 135 (4)

Date Posted: October 29, 2009
Recall Number: Z-0035-2010
Product: WarmAir 135 Thermal Regulating System.
Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V (not sold in the U.S.). Intended for warming patients before, during and after
surgery, and other specialty procedures.
Code Information: Serial Numbers 994-1350001 to
083-1355822..
Recalling Firm/Manufacturer: Cincinnati Sub-Zero Products Inc; 12011 Mosteller Rd Cincinnati, Ohio 45241-1528
Reason for Recall: The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
Action: The firm sent an "URGENT Medical Device Recall' notice via First Class Mail on 2/16/2009 (Note: the letter is dated 2/13/2009). The notice informs the customers of the potential for the device to overheat and of the 'small number of customer complaints received by CSZ concerning this issue. In addition, the notice asks that the customers inspect their units for signs of discoloration indicative of a faulty connector. In the notice, the customers were instructed to return the product to CSZ for repair by contacting their Customer Service division and obtaining a Return Authorization number and specific instructions concerning packaging and returning of the unit(s) for repair. The customer is also instructed to complete the attached Recall Response Form which accompanies the recall notification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution for customer use.
Quantity in Commerce: 2,674 units
Distribution: Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT, VA, CO, MO, IA, AZ, AR, IN, NE, KS, WI, ME, MS, and Puerto Rico.

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

* Indicates information was not available

Adverse Event Table
DeviceCatalog #, Model #, Lot # Event Description
Arizant Healthcare Bair Hugger *,505,* Large rectangular erosion of back status post epidermal loss. Based on localized, rectangular morphology this is most consistent with an extrinsic thermal, ultraviolet radiation, or chemical factor that has led to epidermal necrosis and subsequent blister formation. ====================== Health Professional's Impression ====================== First report was that the burn was caused by a Arizant Bair Hugger ====================== Manufacturer response for Hyperthermia Unit, Forced Air, Bair Hugger (per the site reporter): ====================== Issue is around using these units on pediatric patients. In conversations with Arizant rep, they indicated that this unit should not be used on high. I asked if there was any labeling that they had to indicate this and they do not. The concern is that the unit could reach 56 degrees centigrade without shutting off. The particular piece of equipment that was used on the patient was not identified. All units in surgery were evaluated and determined to meet manufacturer specifications. My immediate concern is that these units have a maximum setting of 43 Degrees C. If the unit has a fault and continues to heat, it can reach 56 Degrees C. I believe this temperature is unsafe for infant/pediatric patients. There needs to be labeling by the manufacturer warning of using higher temperatures, or specific devices manufactured for this type of patient.
Arizant Healthcare Bear Paws *,*,* Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified. Details in this case: Pt used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (std practice). Length of procedure approx 2 1/2 hours. When gown removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.
Arizant Healthcare Bear Paws Flex Ref 81003, 810, GU1025 Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified. Details in this case: Pt used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (std practice). Length of procedure approx 2 1/2 hours. When gown removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.
Arizant Healthcare Inc Bair Hugger *,750,* Post operative patient requested warming blanket. Staff covered patient with a warmer blanket attached to an Arizant 750 warmer. Shortly after staff noticed a "hot" smell near the patient. The smell was quickly narrowed down to the 750 warmer and it was removed from use and Biomed was called. On inspection the Biomed found the molded power cord plug charred. The power cord was replaced and the unit tested OK. This is the second occurrence of this problem on units purchased last year. The other unit had cord issues was approx. 3 months ago.
Arizant Healthcare Inc Bair Paws *,875,* This report is for trending. Our device failure rate is over 35% of our inventory/population over the first year of operation. The device fan motor becomes very noisy over time and has the potential to seize and go into an over temp mode. Potential risk for patient harm if this occurs in an oxygen rich environment such as surgery. In our discussions with the manufacturer, they have agreed to swap out the entire unit.
Arizant Healthcare Inc Bear Hugger *,500 OR,* Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified. Details in this case: Pt used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (standard practice). Length of procedure approx. 2 1/2 hours. When gown was removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.
Arizant Inc Bair Paws Flex Standard Warming Gown *,*,* Patient arrived into the PACU from the OR with large area of redness on the upper left thigh, left flank and left abdomen. The Bair Paws Flex gown was used intra-operatively. Area remained red for approximately two hours. No redness or blistering noted the next day.
Arizant Inc. Bair Hugger *,*,* Soon after turning on Bair Hugger, an explosion and flame occurred from the unit. The bair hugger was immediately removed. Patient assessed. No harm to patient. Problem was found to be the power cord/plug. Wires had become dislodged.
Arizant Medical Bair Paw Warmer *,850,* The machine smelled of burning plastic when the unit was turned on. The smell was noticed by the RN when getting ready to use the machine on the patient. The RN did a safety check and discovered the smell. ====================== Health Professional's Impression ====================== Smell of hot burning plastic
Cincinnati Sub zero Maxi therm Lite 876, *, 769042 Patient using Blanketol III with Maxi-therm Lite blanket. Blanket on top of pt noted to be leaking and saturating patient's gown. Nurse noticed that outer coating of blanket appeared to be coming apart. The blanket was saved.
Cincinnati SubZero Blanketrol II *,*,* Infant in NICU receiving hypothermia therapy to minimize brain injury. Infant noted to have a core temperature of less than the expected 33.5C. Infant was assessed. Cooling blanket was assessed and found to be set at "5C Manual." It had not been switched to "33.5C Automatic." Infant's core temperature dropped to 30C. She was re-warmed after blanket was reset to "33.5C Automatic." Infant's heart rate decreased to 69beats per minute (bpm), no dysrhythmias were noted. While reviewing instruction manual for setup instructions, it was noted that the need to switch from "5 Manual" to "33.5C Automatic" was not written clearly.
Cincinnati Sub-Zero Inc MAXI-THERM Pediatric 274, *, 319075 "An out of box" failure with a cooling mattress. A water leak was discovered when setting up for the admission of a critical infant arriving from an outside hospital. The connector was found to be leaking near the end of the hose. Mattress was taken out of use and replaced by new one without incidence.
Cincinnati Sub-Zero Products, Inc Maxi-Therm 274, *, 319075 Hose noted to be leaking small amounts of water at the connection of the black port on the hose to the black port on the pediatric blanket underneath the baby. Blanket and hose changed and set aside for Biomed.
Cincinnati Sub-Zero Products, Inc. Kool Kit 900,*,8614 The ICU experienced several episodes of the hypothermia blankets leaking. Most of the blankets were the top blanket some were bottom blankets. The leak was large on some of the episodes resulting in the whole bed being changed. Health Professional's Impression: The nurses feel it was a defect in the blanket. Manufacturer response for Kit, Hypothermia Blanket, Cool Kit: Manufacturer felt this was user error but there has been no rhyme or reason to the blankets springing a leak. It has been the vest both top and bottom as well as the blanket. It has been at all different times, when initiating, midway through and at the end. Blankets should last 68-72 hours but are lasting anywhere from 12-48 hours. The nurses had an in-service by the rep, so they know how to use the device.
Cincinnati Sub-Zero Products, Inc. Warm Air *,135,* A new warming unit and blanket was being trialed during surgery. Hose to warming blanket was padded with towel and was not directly on the patient's body. At the end of the procedure, the patient's right knee from mid upper right thigh to mid lower calf was reddened. ====================== Health Professional's Impression ====================== Possibly the connection was taped so that the tape/tension tore part of the paper around the connection and therefore air could escape and blow directly on the patient; or the connection came apart and blew directly on patient; and the blanket not able to be checked under sterile drapes during surgery for problems.
Gaymar *,*,* An elderly patient suddenly became unresponsive while driving his truck. The patient underwent CPR and was brought to the hospital. The patient was placed on a hypothermia protocol. Through this protocol, the patient was cooled with cooling maintained for 24 hours. The patient was then rewarmed per protocol for 12 hours. Nursing noted that the patient had blisters on his right posterior calf.
Gaymar *,*,* An elderly patient was admitted after an out of hospital arrest. The patient was placed on hypothermia protocol. Nursing reported that skin was checked every 2 hours underneath the Gaymar wraps during this protocol. During the protocol's cooling process, the skin was noted to be reddened, cool and intact. The patient's skin gradually became edematous and third spacing was noted. During the rewarming process the patient's skin was noted to be reddened, warm and intact. The skin remained edematous with third spacing. After the rewarming process was completed the patient's back was noted to have fluid filled blisters where the Gaymar wraps were located.
Gaymar *,*,* An elderly patient presented to the emergency room in cardiac arrest. The downtime prior to arrest was unknown. The patient was shocked one time prior to arrival. The patient was ordered to be placed on hypothermia protocol. Nursing noted a few circular blisters on the patient's right side/ chest from the hypothermia vest.
Gaymar *,*,* An elderly patient was admitted to the hospital after an out of hospital cardiac arrest. The patient's total down time was not known. three weeks prior to this incident the patient had a prior myocardial infarction (MI). The patient was placed on hypothermia protocol. After the protocol was completed, nursing noted skin break down on the patient's back. There were multiple sores that appeared to be stage I and II blisters.
Gaymar *,*,* The patient was brought to the emergency room in full arrest. Hypothermia protocol was initiated. The Gaymar device was initiated and set point was programmed for 33 degrees. After 24 hours the rewarming process was started via the Gaymar device. The target temperature was set at 37 degrees, a moderate setting. The patient reached normothermic body temperatures over the next 12 hours. Nursing reported multiple blisters on the right leg of the patient.
Gaymar *,*,* The patient presented with a large inferior posterior ST-elevation myocardial infarction. The patient was placed on hypothermia protocol. Orders were received to maintain body temperature between 32 and 34C for 24 hours with the Gaymar cooling device. Upon removal of the Gaymar blanket the patient was noted to have a palm sized burn with open and closed blebs on the right scapular area on the patient's back. The open areas were partial thickness blistered areas on the right side of the back.
Gaymar *,*,* This patient was an accident drowning victim that had been submersed greater than 15 minutes. The patient was brought to the ED with severe acidosis, and probable anoxic brain damage. Orders were received to maintain body temperature between 32 and 34 degrees C for 24 hours with a Gaymar external cooling blanket. When the hypothermia blanket was removed, the patient was noted to have multiple, scattered fluid filled blisters on his back. Some blisters were intact and some had burst.
Gaymar Industries RaprRound DHV 530, *, * Patient had a prolonged cardiac arrest with CPR. Following hypothermia protocol, the apparatus was removed. Patient had a blister over his back matching the pattern of the hypothermia blanket/apparatus. In our discussions with the manufacturer they have suggested that it must have been used incorrectly and was too tight.
Gaymar Industries, Inc. Medi-Therm III *,MTA6900,* A mechanical cooling system was used to treat the patient's high temperature. Subsequently, dark, reddened regions, non-blanchable to bilateral anterior thighs and lower abdomen. Regions are normal temperature to touch. Regions are not increasing, spreading, or changing in shape, color, or temperature.
Medivance Inc. Arctic Sun 2000-02 or 2000-02L, 2000, * Patient had been on Arctic Sun external cooling for management of neurogenic fevers for 6 days. When pt was turned on the evening of the 6th day, RN found a large blister on back and thighs where the cooling pads had been applied. Two days later the injury was described as frostbite and may be full thickness. Follow-up treatment with silvadene and area debrided a few days later. Clinicians are treating it like a burn. Pads used with the Arctic Sun Cooling Device were product # 317-00 Universal Lot# K9E1804 product # 317-09 Large Lot# K9K0502 Pads were discarded at time of incident.
Smiths Medical ASD Inc Equator - level 1 *,EQ 5000,* At the end of procedure, the device was removed from the patient. At the point of the insertion site of the blower to the blanket, the skin was very red and warm to touch. Skin was also red on the entire left upper arm, shoulder, down to the elbow. By the time discharged from recovery room, the redness had completely resolved.
Smiths Medical ASD Inc Equator Level 1 *,EQ-5000,* At conclusion of surgical case, surgeon removed equator warming blanket and a reddened area on left bicep was present. Upon assessing patient after transfer to PACU, the reddened area was decreased in size but still persisted and remained red in color. No complaint of discomfort from patient.
Smiths Medical ASD, Inc.Level 1 Equator *,*,* Warming system placed on patient during surgical procedure and removed at the end of the procedure. The skin proximal to the location of the Level 1 Equator blower was reddened in an area the size of a grapefruit. It is believed the hose was connected to the blanket throughout the procedure, and the case was approx. 2hrs in duration. The patient's body was not touching the hose.
Smiths Medical ASD, Inc.Level 1 Snuggle Warm *,*,* Once an OR procedure was complete, warming blanket were removed. At this time red marks were observed on the leg in the shape of spiral shape like blower hose to blanket. Redness areas dissipated by the time the patient left the OR.
Smiths Medical EQ 5000 *,EQ 5000,* During neuro surgery a burning smell was identified in the Surgery suite. The convection blanket warmer was the cause of this smell. The disposable blanket was also removed from the patient because it showed minimal presence of char on venting holes and other sections. Removed from service and brought in the Biomed Dept.

Additional Information:

1. 21CFR870.5900 Thermal Regulating System. Available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=870.5900

2. Class 2 Recall - BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850. Information available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88575

3. Class 2 Recall: WARM AIR WARMING UNIT. Information available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86906

4. Class 2 Recall: WarmAir 135. Information available online:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79327

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Updated November 1, 2010

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