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U.S. Department of Health and Human Services

MedSun: Newsletter #19, December 2007

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Newsletter #19, December 2007

Articles

MedSun Sites Contribute to Public Health Notification from FDA, CDC, EPA and OSHA: Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment

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This notification describes the hazards of using excess cleaning and disinfecting liquids on certain electronic medical equipment and recommends ways to avoid these hazards. The Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Environmental Protection Agency (EPA), and Occupational Safety and Health Administration (OSHA) collaborated to develop this notification. Over the past two years these Federal agencies have learned about and worked to address problems associated with inappropriate use of liquids on electronic medical equipment. Several MedSun Representatives and individuals from MedSun facilities were instrumental in helping analysts from FDA and the other Federal agencies to understand the root and scope of the problem.

Essential to the genesis of this document were four MedSun reports received from two MedSun hospitals documenting the degradation of plastic on IV pumps due to the use of certain disinfectants. In addition, there were infusion pump fires associated with fluid ingress entered into the MAUDE database. Based upon these reports and information garnered during follow up with the MedSun site reporters, the CDC was notified and formal interviews were set up with the original MedSun sites that reported the problem, plus three additional MedSun sites. These interviews were arranged with the individuals that were responsible for overseeing the cleaning of infusion pumps at their MedSun institutions and involved persons from Central Supply, Housekeeping and Biomedical Engineering. During these interviews, individuals were asked about their infusion pump reprocessing policies and procedures and if they had observed degradation problems with the pumps’ housing, or malfunctioning of the pumps due to fluid ingress. These interviews revealed the critical nature of the problem and led to the involvement of two other federal agencies, EPA and OSHA. Together in a notable act of collaboration, the 4 Federal agencies, FDA, CDC, EPA and OSHA drafted the Public Health Notification. Individuals from MedSun sites were involved in reviewing and providing feedback on these drafts.

Problems associated with the use of excess cleaning and disinfecting liquids is not limited to IV pumps and may be relevant to any equipment that has unsealed electronic circuitry or components. The equipment malfunctions could result in life-threatening events to patients such as over-infusion of medications, loss of life-supporting drug therapy, and loss of patient ventilation. In this notification, root causes are noted and recommendations to avoid the hazards described above are outlined.

Additional Information:

For the full text of this Public Health Notification go to
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062052.htm

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Danger: Beware of Unretrieved Device Fragments

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By Robert A. Fischer, RN, MSN
From Nursing2007, Volume 37, Issue 11


During a cardiac catheterization, a fractured guide wire lodged in a coronary artery, causing coronary artery perforation. Attempts to retrieve it failed, and the patient died from cardiac tamponade.

What went wrong?

An unretrieved device fragment (UDF) is a broken or fractured portion of a medical device that was never intended to remain in a person’s body for an extended time. By definition, the UDF is left in the body either because no attempt was made to retrieve it or because the attempt was unsuccessful.

In the case described above, the health care provider manipulated the guide wire into a shape for which it wasn’t designed. Weakened by the bending, the guide wire
fractured during the procedure. Catheter and guide wire fractures that result in UDFs can be caused by these inappropriate techniques:

•withdrawing a catheter through or over a needle
•shaping a device to conform to the patient’s anatomy when the device wasn’t designed to be reshaped
•using undue force and torque (rotational force) on insertion or withdrawal
•improperly manipulating a catheter
•using devices that are too small or too large
•using a device for an off-label purpose, such as using a biliary stent in the carotid arteries
•using old or worn multiple-use devices, such as endoscopes. Also, a device that has flaws in its manufacture, design, or materials or that’s been damaged in shipment or storage may be used inadvertently. Failure of a device can cause it to tear, shear, kink, fold, chip, break, rip, crack, or crimp and can result in UDFs.

Burns and other serious injuries

Each year, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health receives over 1,000 reports about UDFs. These reports involve many types of devices and several serious injuries and patient deaths.

Retained devices may be made of materials that aren’t intended for extended use, and their fragments may have sharp surfaces. Besides occlusion, UDFs can lead to tissue injury and other complications. For example, metallic fragments within the body may potentially move or become warm during magnetic resonance imaging. If the metal is close to a vital organ or blood vessel, it may cause serious complications. According to reports in the literature, some patients don’t know they have a potentially harmful device fragment in their body, so they don’t report it.

What can you do?

Take these steps to minimize the risks of UDFs:
•Question your patient and review his medical records for any history of retained devices or fragments. Make sure that any UDF is documented in his medical record and notify the health care provider.
•Before using it, inspect any device for breaks or other flaws. Remember, even a new device can have manufacturing flaws or be damaged during shipment or storage.
•Follow the manufacturer’s device labeling and instructions for use, insertion, and removal.
•Use best practices for patient positioning, device insertion and removal, and troubleshooting.
•Review your facility’s policies and procedures about what to do if a patient retains a device fragment.
•If a patient has a UDF, he should be informed so he can report it to other caregivers and avoid complications during future medical treatment or testing.
•Follow your facility’s policy for reporting UDFs. Also report all UDF events to the FDA through the MedWatch reporting program.
___________________

The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, who coordinates Device Safety, is a nurse-consultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md.
___________________

Robert A. Fischer is an anesthesia and central venous catheter device nurse-consultant at the Center for Devices and Radiological Health.


Additional Information:

MedWatch reporting program
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

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CDRH Software Forensic Lab Upgrade

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In consultation with other federal agencies involved with software integrity issues (e.g., Department of Defense, FBI, National Institute of Standards and Technology, NASA), the CDRH Software Forensic Laboratory has leveraged the latest academic research to implement a state-of-the-art software forensic capability, according to the 2006 CDRH Annual Report. This technology is currently employed in the automotive and aeronautical industries. In an interview in Medical Devices Today, Brian Fitzgerald, the Deputy Director of OSEL’s Division of Electrical and Software Engineering, discusses the benefits of the recently upgraded “software forensics lab.”

Traditionally, in order to minimize risk, FDA has relied on validating the software design processes in the pre-market approval process. Fitzgerald explains that this approach is good but means that sometimes software errors do not become evident until after the device has been FDA approved and is in use. The recent upgrade to the forensic lab however, now makes it possible to automate the search for coding vulnerabilities in complex software. As stated in the CDRH 2006 Annual Report, this method, called “static analysis,” may be used in any phase of the product life cycle, but is particularly valuable in understanding the root causes of adverse events due to software failures. The report also notes that this new capability was used to the great benefit of CDRH in several recent high-profile compliance cases.

But static analysis remains a resource-intensive process and Fitzgerald explains that “Only cases that present an imminent public health threat warrant the level of effort required to do the analysis.” His hope is that in the future manufacturers will invest in this technology and provide “static analysis” before a product is submitted to FDA for pre-market approval.

Additional Information:

Read this article in full at
http://www.medicaldevicestoday.com/2007/10/cdrh-software-f.html

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AHRQ Articles of Interest

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New AHRQ-Funded Study Finds Technical Errors Are Pervasive in Surgical Procedures

Most surgical adverse events are a result of technical errors, such as manual errors and errors in judgment and knowledge, and primarily involve experienced surgeons during routine operations, according to a new AHRQ-funded study in the November issue of the Annals of Surgery. Researchers recommend that surgical safety research should focus on improving decision-making and performance in routine operations for complex patients and circumstances.

Many Errors by Medical Residents Caused by Teamwork Breakdowns, Lack of Supervision

A new AHRQ-funded study shows physicians-in-training are highly vulnerable to making medical errors that stem from teamwork breakdowns, especially a lack of supervision by experienced staff. Teamwork breakdowns involving medical residents, fellows, and interns (first-year residents) also caused a significant number of errors to occur during patient handoffs, researchers found.

Latest Issue of AHRQ WebM&M Available Online

The October issue of AHRQ WebM&M is now available. The Perspectives on Safety section features an interview with David Marx, J.D., on the concept of "Just Culture," which has been increasingly embraced as a way to balance the desire to create a "no blame" environment and the clear need for accountability. In the Comments and Commentary section, a case study involving the response to a cardiac arrest in an outlying area of the hospital complex is discussed. You can receive CME, CEU, or trainee certification by taking the Spotlight Quiz.

AHRQ News and Numbers

One of every 20 (or 5 percent) of the roughly 368,600 patients treated in U.S. hospitals in 2005 for methicillin-resistant Staphylococcus Aureus, or MRSA, died. Most of the patients who died of this highly dangerous antibiotic resistant staph infection were elderly or low income. The death rate for hospitalized MRSA patients was higher than the 4 percent death rate for hospitalized tuberculosis patients, another potentially deadly illness. [Source: Agency for Healthcare Research and Quality, HCUP, Infections with Methicillin-Resistant Staphylococcus Aureus (MRSA) in U.S. Hospitals, 1993–2005]

Additional Information:

New AHRQ-Funded Study Finds Technical Errors Are Pervasive in Surgical Procedures
http://www.ahrq.gov/news/ptsnews/ptsnews38.htm#1

Many Errors by Medical Residents Caused by Teamwork Breakdowns, Lack of Supervision
http://www.ahrq.gov/news/enews/enews242.htm#1

Latest Issue of AHRQ WebM&M Available Online
http://webmm.ahrq.gov/perspective.aspx?perspectiveID=49

Agency for Healthcare Research and Quality, HCUP, Infections with Methicillin-Resistant Staphylococcus Aureus (MRSA) in U.S. Hospitals, 1993–2005

http://www.hcup-us.ahrq.gov/reports/statbriefs/sb35.pdf

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Reporting Tip

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You may have wondered why we often ask if you returned the device involved in a report to the manufacturer, or suggest that you do so. We would like to clarify how this adds value to your report.

In many cases, in order for FDA analysts to obtain meaningful information when they contact the manufacturer about your report, the manufacturer, understandably, needs to have had the opportunity to examine the device. If you were not able to provide the device to the manufacturer, they will often respond that they simply cannot comment on what may have occurred with a device that they could not examine or they may state that the adverse event cannot be attributed to their device. In such cases, the FDA’s ability to follow up on your report, however well written, may be very limited.

We understand your concern about releasing a device that has potential to be involved in litigation, to the manufacturer. Putting those instances aside, we strongly suggest that you make every attempt to return defective or problematic devices to the manufacturer for analysis. Or you can request an on-site manufacturer analysis. This, of course, is a necessity with large fixed devices such as CT scanners. Alternatively, if the device is not available, you can inform the manufacturer that you are sending an unused device from the same lot # for evaluation instead. In instances where the packaging was thrown away and all device identifiers are therefore not available, returning the device to the manufacturer allows FDA to get more device identifiers from the manufacturer after the device is examined.

If you have questions about how to return products to the manufacturer for analysis, contact your hospital’s Material Management or Purchasing department. In most cases they have frequent contact with representatives from these companies and have procedures in place for returning items to them. All parties have the opportunity to benefit when a device involved in an adverse event is returned to the manufacturer; the FDA is better able to follow up, the manufacturer gains a better understanding of failures that occur with its product, and you may learn some lessons about the use of that product or what the manufacturer may be doing to prevent a future occurrence.

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DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

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Question:
Are other hospitals experiencing problems with head rests during neurosurgery cases? We have recently noted some "wobble" in the c-clamp after the pins are tightened. We have had two cases where patients received small lacerations due to movement of the pins. The manufacturer recommended that we buy another product at an additional price to "cure" the wobble.

Comment:
A search of the MedSun database reveals that 13 similar reports about problems with headrests or skull clamps have been received from 9 hospitals since August 2002. All involved Mayfield products. A skull fracture occurred in one report. In 10 of the reports a scalp laceration was sustained and sutures or staples were required in 5 of these 10 reports. See spreadsheet below for further details. These MedSun reports have been edited for clarity and in some instances have been summarized.:

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Model #/Other Device #: A1059
Event Description: On turning patient to prone position, one of the three skull pins slipped and cut the patient's skin. The clamp was reapplied in different area of skull.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Event Description: Partway through laminectomy, the head/neck very obviously changed position. Significant blood loss noted around pin sites and surgeon found large laceration at original pin site (single pin site) going through to skull and periosteum was removed. Another laceration, slightly less deep, was perpendicular to this. Lacerations were cleaned and sutured. Pin not found in original position and was fully retracted. This was a loaner clamp.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Event Description: Left sided pin was tightened to a standard torque of 60 lbs. As patient was being positioned, the pin slipped and a 1.5 cm laceration of the scalp resulted on the left temporal region. The resident sutured the laceration. This was a loaner set. C-clamp and pins for the Mayfield were replaced with another set.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp, Mayfield Headrest
Event Description: Patient was placed on a Mayfield headrest while on a stretcher. Patient was transferred onto OR bed and connected to the base of the Mayfield headrest. Once connected it would not stay locked on to the patient's head, and the patient suffered two 4-6 inch scalp lacerations. Large amount of blood loss. Patient put back on stretcher. Wounds were sutured.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Model #/Other Device #: A1059
Event Description: Doctor applied skull pins to patient's head in a Mayfield headrest. While applying pins, the doctor stated that "the tensioning device is not releasing." He immediately pulled the skull pin out of the patient's head and ordered a stat skull CT. CT revealed a skull fracture at pin site.

Manufacturer: Integra LifeSciences Corporation
Device: Type Skull clamp
Event Description: Patient's head was placed on skull pins. After they tightened the device, the skull clamp slipped from the lock position to unlock which caused a tear on the patient's head. Fracture stable.

Manufacturer: Integra LifeSciences Corporation
Device: Type Skull Clamp
Model #/Other Device #: A1114
Event Description: After case patient was undraped and it was noted that the 3 pin headrest had slipped causing a 1 1/2 inch cut in the patient's scalp that required staples to close.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull clamp
Model #/Other Device #: A1059
Event Description: The patient's head slipped out of pins due to Mayfield locking system failure. Patient's scalp torn out 5 or 6 cm. Physician stapled scalp.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull clamp
Event Description: Pins slipped after secured to patient's head. Pt sustained a laceration to the head.

Manufacturer: Cardinal Health Medical Products and Services
Device Type: Head Holder
Event Description: When putting patient's head in Mayfield, the swivel adapter did not hold. Surgeon supported the head until adapter was changed. At the end of the case, base unit slipped about 1/2 inch. No injury to patient. The washers have been slipping on these devices and the company representative has tried replacing these, but they continue to slip.

Manufacturer: Cardinal Health Medical Products
Device Type: Head Holder
Model #/Other Device #: M1570
Event Description: The patient was positioned in the Mayfield head rest. After start of case, anesthesia noted that the patient's orbits were resting on metal. The physician broke scrub and repositioned the head.

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull clamp
Model #/Other Device #: A2000
Event Description: Patient with C-4 complete injury in Operating Room for cervical stabilization. Mayfield skull clamp used. Just prior to incision, patient's head noted to drop slightly, head was then supported. The locking mechanism, the part that rotates to secure position, had separated from the stationary part of the clamp. Patient neurologically at baseline

Manufacturer: Integra LifeSciences Corporation
Device Type: Skull Clamp
Model #/Other Device #: A1059
Event Description: Patient positioned for neurosurgical procedure using Mayfield skull clamp. Clamp positioned and locked into place with a torque setting of 60 lbs. When surgical drapes were removed after procedure, 1 cm laceration noted on the patient's scalp. Surgeon noted torque gauge read 40 lbs. when laceration discovered. Wound closed with 3-0 vicryl.

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LabNet

Of Special Interest to Laboratorians/LabNet

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New AHRQ Guide Helps Clinicians Determine Necessary Preventive Medical Tests for Patients

AHRQ’s 2007 Guide to Clinical Preventive Services is now available to help clinicians determine which preventive medical tests are necessary for patients. Based on recommendations from the U.S. Preventive Services Task Force, the guide contains recommendations on 58 clinical preventive services made by the Task Force from 2001 to 2006.

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KidNet

Of Special Interest to Pediatric and Neonatal Staff/KidNet

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Food and Drug Administration Amendments Act of 2007 Addresses Pediatric Health Issues

On September 27, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007. This new law represents a very significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded. Two other important laws were reauthorized: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Both of these are designed to encourage more research into, and more development of, treatments for children. Also in this law is the new “Pediatric Medical Device Safety and Improvement Act of 2007.”

Pain Management Competency Evidenced By a Survey of Pediatric Nurses

Using an assessment tool that measured nurses’ knowledge and attitudes regarding pain, this multi-center study looked at how these factors influence a nurse’s ability to attend to children in pain. A total of 295 nurses participated in this multi-site study conducted at eight pediatric hospitals. Scores from the assessment tool were correlated with demographic data and showed that nurses with less than two years of nursing experience had significantly lower scores than more experienced nurses. Additionally, involvement in professional nursing organizations or nursing committees also correlated with higher scores.

Reprinted from Pediatric Nursing, 2007, Volume 33, Number 4, pp. 307-312. Reprinted with permission of the publisher, Jannetti Publications, Inc., East Holly Avenue, Box 56, Pitman, NJ 08071-0056; (856) 256-2300; FAX (856) 589-7463; Web site: http://www.pediatricnursing.net. For a sample copy of the journal, please contact the publisher.

Additional Information:

Food and Drug Administration Amendments Act of 2007 Addresses Pediatric Health Issues

http://www.fda.gov/oc/initiatives/HR3580.pdf

Pain Management Competency Evidenced By a Survey of Pediatric Nurses
http://www.pediatricnursing.net

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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 September 1 through September 31. 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(s): Ventilator, High Frequency, 3100B Peds/Adult
Manufacturer(s): SensorMedics Corporation
Problem: The respiratory therapist reports that the ventilator settings were drifting. On each ventilator check, the knobs were being turned a little to obtain the original settings. The settings were set as follows: mean airway pressure (MAP) 32, amplitude (Delta P) 75, frequency (Freq) 4, and O2 100%. The ventilator was checked per protocol and the ventilator settings were as follows: MAP 21, Delta P 92, Freq 0.6, and O2 60%. The arterial blood gases (ABG’s) were poor to begin with; they had become slightly worse but returned to baseline once the ventilator was changed out.

Device(s): Humidifier, Heated, Respiratory, Comfort Flo Humidification System Catalog# 2411-03; Respiratory Circuit, Heated Wire ConchaTherm IV Plus Catalog# 400-50; Nasal Cannula Comfort Flo Catalog# 2411-03
Manufacturer(s): Teleflex Medical (Hudson Respiratory Care, Inc.)
Problem: Baby was on Hudson RCI Humidification System ConchaTherm IV Plus ref# 400-50. System included Comfort Flo Humidification System including Concha Column and tubing set ref# 2410, Comfort Flo Nasal Cannula (NC) ref # 2411-03 and Soln Water Concha Pak 1650ml ref# 381-50. Baby was on High Flow Nasal Cannula (HFNC) 60%@4 liters per minute (LPM). The Concha suddenly overflowed and shot water down the tube into the pt’s nares. Nurse disconnected the NC from the Concha. Tubing continued to flow safely onto the floor. RT’s changed out the concha. RN assisted in blowby oxygen as the saturation was 37. There was no injury to the baby other than desaturation to the 30’s when water first entered the baby’s nares. Device setting at time of malfunction was Adult +/- 3 degrees. Respiratory therapist thinks that due to the soft and very pliable nasal prongs, it bends and kinks off causing back pressure in the Concha until it explodes out.

Device(s): Tubing, Resuscitation Bag, CPR bag with Universal O2 Connector
Manufacturer(s): Mercury Medical
Problem: The patient was noted to be non-responsive so the basic life support protocol was initiated and the EMS called. Staff members attempted to connect stock CPR bags to the O2 tanks; however they were unable to utilize the CPR bags so an O2 nasal cannula was used in the interim. After this incident, it was discovered that the O2 tanks and CPR bags were incompatible since the O2 tanks had a “standard” connector, which had been phased in about one year ago. All sites were notified to check their stock to ensure they had only the standard connectors on all CPR bags. The purchasing department was aware that only standard connectors were allowed, however this incident resulted from the use of old stock that was not found and purged. The off-site rental center still had old style of connector, or “universal” connector on their CPR bags. This incident occurred at a remote location that does not frequently use O2, and apparently did not have to “bag” a patient until recently. To address this issue internally, it was first verified that the old connectors were purged by sending a flyer out to all department managers, followed by a written e-mail or a verbal confirmation of receipt from each of them. Additionally, it was confirmed that all new CPR bags will have the standard (new) connectors and that the purchasing department does not have the old style in their system. (For additional information about responding to cardiac arrest in outlying areas of the hospital see the Case & Commentary article featured in the October 2007 AHRQ’s WebM&M http://webmm.ahrq.gov/case.aspx?caseID=162)


CARDIOVASCULAR

Device(s): Catheter, Thermal Regulation System, Coolgard Start -Up Kit
Manufacturer(s): Alsius Corporation
Problem: The patient presented with cardiac arrest and Code Freeze was initiated. The cooling process was started. It was noted that the tubing that connects the machine to the catheter was not functioning properly due to a leak in the tubing. The tubing was exchanged without any problems.

Device(s): Defibrillator, Lifepak 20 Model# 3202487
Manufacturer(s): Medtronic, Inc.
Problem: Our facility has 36 Lifepak 20 defibrillators. Over the last few months we have had 5 units with a defective Power Module printed circuit board that enables the battery to be charged. One of the 5 units has had the circuit board replaced twice. When the units are unplugged to be used, the battery fails. We have noticed that the self-test is not totally reliable. If the Power Module PC board fails, and the unit remains plugged in to the AC mains power, the unit will pass the self-test and prints “Test Successful”, however, when the unit is unplugged, the battery is depleted and the unit fails. This was discovered when a nurse was ready to use this device and the battery failed. The unit then had to be plugged in to the nearest outlet. The five units which have had failures of the Power Module PC board are listed in this report. All defibrillators in the facility have had the recall issues involving the batteries, and the software upgrade installed as necessary.


GASTROENTEROLOGY/UROLOGY

Device(s): Filter, Dialysis Machine, Continuous Renal Replacement Therapy (CRRT) Model# 7106505
Manufacturer(s): B. Braun Medical, Inc.
Problem: CRRT Filter UF alarming “UF greater than expected.” UF variable amounts despite Calc UF. Taking off more than set amount.

Device(s): Dialysis Machine, Continuous Renal Replacement Therapy (CRRT), Prisma
Manufacturer(s): Gambro Renal Products, Inc.
Problem: RN was attempting a temporary disconnect procedure to pt on Continuous Venovenous Hemodialysis (CVVHD). He attached the NSS to the return line & pressed the return button. The pump started running backwards (the blood was infusing into the flush bag.)The RN stopped the pump and retraced the lines and had it double checked by another RN who confirmed correct set up. He switched the line since it was running backwards-to see if this would make a difference in flow. When he pushed the return button this time the machine started to shake and alarmed “Return Pressure Too High”. Pump stopped. Circuit discontinued without returning blood to patient. Patient’s hemoglobin and hematocrit stable. Pump tagged and removed from service. Evaluation by Biomed could not reproduce the problem-although original tubing/set up had been removed. For Biomed personnel, blood pump loaded and unloaded normally, all pressures and solenoids were verified along with all scales.

Device(s): Dialysis Machine, Multi-Therapy NxStage System One Model# CYC-D2E
Manufacturer(s): NxStage Medical, Inc.
Problem: Taken from staff report: “An IV tech tripped on the power cord - the machine was plugged back in and went through a power recovery. The blood and therapy pumps continued to function appropriately and the computer seemed fine until the next hour’s volume history was reviewed. The computer reported that -16.86 liters of therapy fluid was used but the machine was set for +2.4 liters. It also reported that -1262 mL of ultrafiltration were removed but the machine had been set for 168 mL. The next hour’s values were similarly incorrect. The RN returned the patient’s blood and switched to a new machine. Soon after, the patient’s blood pressure was declining and the RN had to restart the neosynephrine drip. The machine was red tagged and sent to Clinical Engineering.” Manufacturer’s representative later evaluated the machine and verified the machine was working properly. According to the manufacturer, the machine uses a separate computer for the history display. The history computer data can apparently be corrupted by an unplanned shutdown. Since staff rely on the history to monitor the patient, any obviously erroneous data is cause to discontinue the machine and replace it. We have actually had the same problem with several machines, mostly following a “controlled” shutdown and re-boot.


GENERAL HOSPITAL

Device(s): Syringe, Insulin
Manufacturer(s): Becton Dickinson
Problem: The nurse correctly calculated the patient’s next dose of insulin as 8.5 units. The nurse went to the drawer containing the insulin syringes, each of which was in a separate package (0.3 cc (30U), 0.5 cc (50U), and 1cc (100U) syringes). The nurse mistakenly thought she had taken out a 10 unit syringe, but in fact, she took out a 100 unit syringe. The nurse drew up what she thought was 8.5 units of insulin, verified this with the charge nurse, and administered it to the patient. As she was withdrawing the needle, she realized there was an additional “0” next to what she thought was a “10” marker on the syringe. The nurse immediately ordered D10 (dextrose 10%) from the pharmacy, called the physician, and the lowest glucose reading obtained was 61. In reviewing the insulin syringes that were available, all three sizes have orange colored needle covers. Although the sizes are different, the differences are not extreme to a user who only occasionally administers insulin.

Device(s): Tubing, IV Lifeshield Lot# 53072 Catalog# 11965-68; Other Device# Any 53 series lot number
Manufacturer(s): Hospira Global Medical Affairs
Problem: Hospira recently made a change to their ‘Cair Clamps’. The Cair Clamp is the white plastic roller clamp on their gravity drip IV tubings. We are not certain yet in which lot number the change began (Their lot numbers are sequential). We do know that anything that is Lot number 52-113-4W or lower is the old style Cair Clamp. We were not notified of the change prior to discovering it ourselves - spurred by concerns from our hospital. The change in the roller clamp affects how the tubing is compressed and how the rate of flow of the IV is regulated.

Staff from our hospital related that:
1. “Roller clamp does not regulate IV drip properly. Runs all or nothing”.
2. “Runs too fast or not at all. Very Difficult to Run. Problem not with IV Site.”

The problems that were encountered at the hospital that lead to the request to pull lot numbers is directly related to the product change in the Cair Clamps. We were able to confirm this today when we visited the PACU and talked through the matters. The result of this is:

1. We can utilize lot number 52-112-4W that we previously requested be pulled from stock. It was intermixed with newer lot number stock at the hospital that had the actual problem.
2. The hospital is working on sequestering lot numbers of the product that are 52-133-4W or lower.
3. We will work with Hospira and Nursing on long term solutions. To date, Hospira has not provided the hospital with the list of lot numbers this change started affecting. We believe this new clamp is also going to be used on all their other sets, but Hospira has not given us dates on the roll out. (Note from FDA: Similar roller clamp problems have been seen with other IV tubing manufacturers.)

Device(s): pump, PCA II
Manufacturer(s): Baxter Healthcare Corporation
Problem: Biomed received several reports of Baxter PCAII pumps “not delivering meds”. End result of the extensive investigation by Biomed discovered a very dangerous scenario - potential patient injury or death - that may have already been played out (perhaps numerous times, including other possibly pediatric uses of this device), that went undetected until now. The scenario goes like this: A pediatric patient is put on a Baxter PCAII pump for pain relief. Certain medications (such as fentanyl and hydromorphone) must be used at high concentrations to be safe and effective. Dose is set for 0.2mL, with a 10 minute lockout period (standard), with possibly an initial bolus of 0.5mL programmed in as well. PCA button is pushed and meds are “delivered”. Unknown to staff, the line is occluded (perhaps kinked or clamped off), so no med is actually delivered to the patient. The patient continues to request meds, as they are in pain and not receiving meds. Pump “delivers” a max of 0.2mL every 10 minutes, without it actually getting to the patient. Over an hour or so, 1.9mL of fentanyl or hydromorphone are “delivered” before the pump recognizes occlusion and alarms. RN responds to alarm, sees patient in a lot of pain, and perhaps either knowingly (unclamps) or unknowingly (line becomes unkinked), fixes the occlusion problem. At this point the RN has just released a backpressure of 1.9mL in concentrated meds, which is immediately delivered to the patient. If the RN does not recognize that this just happened, she may also manually deliver another 0.5mL bolus to relieve the patients obvious pain. Total “bolus” of med delivered = 2.4mL of fentanyl or hydromorphone. This is 5x the normal bolus amount, and 12x the normal dose request amount. On some pediatric patients, this could easily be potentially fatal! (Note: manufacturer specs for occlusion testing say to set rate to 99mL, device should alarm occlusion within 3 minutes. Quick math reveals up to 4.95mL could be “delivered” before it recognized the occlusion and alarms. This would be potentially even more deadly, and the device would still be within manufacturer’s specifications). Due to the easily disguised nature of this problem, this scenario has probably been played out before when used in this manner (pediatrics). Perhaps the pumps were even marked as “defective” and sent out for repair. Testing by Biomed’s and manufacturer’s would reveal the device is working “perfectly” within specifications, and would therefore probably be closed out as “no problem found” or perhaps “operator error suspected”. We feel this is a significant patient safety issue that other pediatric users of this device should be made aware of ASAP. As a remedy, we have sent out a housewide e-mail, and have a special nursing skills day station set up. We are exploring other (newer) devices that may be more sensitive to occlusion alarms.


GENERAL SURGERY

Device(s): Transanal Endoscopic Microsurgery System Model# 2232
Manufacturer(s): Richard Wolf Medical Instruments Corp.
Problem: After completion of a transanal endoscopic microsurgery procedure it was noted that a black nitrogen tank had been connected to the insufflator when a gray carbon dioxide cylinder should have been used. When the E-cylinder connecting yoke was examined it was noted that it could be attached to the cylinder valve without the safety index pins coming in contact with the gas cylinder valve body. Further examination revealed that the yoke had been assembled with a dual threaded fitting that was too long for the yoke body. This resulted in the plastic sealing washer making contact with the cylinder prior to safety pin insertion. This defect would have allowed connection to any gas cylinder with any safety pin key configuration.


NEUROLOGY

Device(s): Attachment, Drill, Surgical, Dura Guard Model# 5400-10-58
Manufacturer(s): Stryker Instruments
Problem: There are four attachments for the Stryker power drills that are used when raising the bone flap for craniotomies. Four of these attachments have demonstrated poor performance. After further investigation, it was discovered there was rust or debris deposits in a supposedly sealed area of the device that cannot be cleaned. Presence of this foreign material could contaminate the sterile field. There have been no patient injuries at this time. The manufacturer is aware of the issue and informed us that they are redesigning the attachments.

Device(s): Software, Stereotactic Radiosurgery XSight Spine Software, Model# XSight Spine Version 7.1.2
Manufacturer(s): Accuray, Inc.
Problem: The patient has metastatic lung cancer to the spine and other areas. The XSight software is designed to detect, correct and help the Cyberknife track the target lesion. Specifically, the software is supposed to detect orientation and anterior/posterior, superior/inferior, left/right and 3 rotations that include pitch, left/right roll and yaw. The left/right roll would get locked in on a certain number. One of those numbers would allow you to treat. You can reposition the patient and roll the table 5 degrees in either direction. The left/right roll number remains the same and provides a “start” button that allows you to treat. It was then noted that this existed for her prior treatment and she was treated 5 times with this error. No known sequelae to patient, but any sequelae is not likely to show up for months to years.


ORTHOPEDIC

Device(s): Attachment, Shoulder Positioner, T-Max Manufacturer(s): Tenet Medical Engineering, Inc.; Smith and Nephew, Inc. Endoscopy Division
Problem: A patient was being positioned in the OR for a right shoulder arthroscopy using a T-Max Shoulder Positioner supplied for trial use by a representative from Tenet Medical Engineering Company. Prior to elevating the shoulder positioner portion of the table, the stability of the table attachment was checked. When the extension was raised, part of the table collapsed causing the intubated patient to slip. The Anesthesia and OR team caught the patient as well as supported the table to prevent it from falling. The surgery had to be postponed and the patient was extubated successfully. The patient had minor skin abrasion as a result of the incident. One staff member who helped support the patient and table from falling completely ironically sustained a shoulder injury. Analysis of the event revealed that the clamp on the extension failed when it was raised. Prior to the failure, the proper procedures were followed. This device will not be used for future procedures.


LABORATORY/DIAGNOSTIC TESTS

Device(s): Software, Laboratory Information SOFTMic(GUI), Model# SOFTLabMic 4.0.1 Build 14:5
Manufacturer(s): SOFT Computer Consultants, Inc.
Problem: Soft Computer Consultant Laboratory Information System loaded comprehensive patch 4.0.1 build 14:5 this past spring. Since then SoftMic result entry lost an important feature that alerts technologist when someone else is in the same patient database. Previous to the comprehensive patch, there was a properly functioning warning message that would alert the technologist when someone else was using the same patient database. Without this warning message, the following patient result entry could potentially not be saved. This is a user definable function that could lead to the loss of patient data.

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Updated December 1, 2007

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