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U.S. Department of Health and Human Services

MedSun: Newsletter #17, September 2007

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Newsletter #17, September 2007

Articles

MedSun Annual Report: November 2005 through January 2007

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Below you will find the MedSun Annual Report which highlights MedSun accomplishments and activities from November 2005 through January 2007. Report is organized by:
•MedSun Initiated Recalls November 2005 - January 2007
•MedSun Successes – Manufacturers in Action! (organized by device specialty)
•FDA Center for Devices and Radiological Health (CDRH) Teams Based on MedSun Reports
•Surveys/Interviews
•Interviews & Site Visits
•Safety Tips & Articles
•Site Visits to MedSun Hospitals

MedSun Initiated Recalls November 2005 - January 2007

Device: Vapotherm Respiratory Gas Humidifier, Model 2000i
Date Posted: January 19, 2006
Manufacturer: Vapotherm, Inc.
Recall Number: Z-0360-06
Code Information: All S/Ns of the Vapotherm Model 2000i are affected.
Reason for Recall: Instructions for cleaning and disinfection not adequate to prevent infections.


Device: QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
Date Posted: November 02, 2005
Manufacturer: Medtronic Emergency Response Systems, Inc.
Recall Number: Z-0116-06
Code Information: Cables do not contain serial numbers. Therapy cable part number: 3006570-006 and below
Reason for Recall: Potential for voltage pins in connector of therapy cable to break.


Device: Gambro Prisma® Continuous Renal Replacement System
Date Posted: Initiated August, 2005
Manufacturer: Gambro Renal Products, Inc.
Recall Number: NA
Code Information: Model/Catalog Numbers: 018080100, 018080101, 018080001D. All serial numbers
Reason for Recall: Critically ill patients receiving continuous renal replacement therapy may suffer excessive fluid loss if caregivers override the device’s “Incorrect Weight Change Detected” alarm. These alarms alert caregivers to a potential fluid imbalance in the patient. If the cause of the alarm is not addressed, an excessive amount of fluid can be removed from or administered to the patient.


Device: Gambro Prisma M100 preset
Date Posted: April 05, 2006
Manufacturer: Gambro Renal Products, Inc.
Recall Number: Z-0705-06
Code Information: Lot numbers 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865, 05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G, 05G0556G, 05G0760G, 05G1366G
Reason for Recall: After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.


Device: Gambro Prismaflex Hemodialysis Machine
Date Posted: October 12, 2006
Manufacturer: Gambro Renal Products, Inc.
Recall Number: Z-0032-2007
Code Information: Catalogue Number 6023014700 Serial numbers: PA0101 to PA0681
Reason for Recall: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.


Device: Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrat¬ed bed) fitted with 9001W005J Elevator Module
Date Posted: January 11, 2007
Manufacturer: Fisher & Paykel Healthcare Ltd.
Recall Number: Z-0485-2007
Code Information: Various lot numbers
Reason for Recall: This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result.


Device: Venoscope Neonatal Transilluminator
Date Posted: October 28, 2006
Manufacturer: Venoscope LLC
Recall Number: Z-0116-2007
Code Information: Model NT01
Reason for Recall: Excessive heating due to incorrect wire assembly process.


Device: Hospira brand Plum A+I.V. Infusion Pump
Date Posted: January 12, 2006
Manufacturer: Hospira Inc
Recall Number: Z-0389-06
Code Information: Various serial numbers
Reason for Recall: The pump may shut-off prematurely during battery operation without providing adequate response time when ‘E320’ service warning message appears.


Device: Maquet Ventilator System SERVO-I V3.1 PC1777
Date Posted: February 9, 2007
Manufacturer: Maquet Inc.
Recall Number: Z-0372-2007
Code Information: Article # 64-87-800 Serial # 02400-03300
Reason for Recall: Reported failures of the SERVO-I ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.


Device: Convertors Cardiovascular Split Pack II
Date Posted: October 21, 2006
Manufacturer: Cardinal Health
Recall Number: Z-0059-2007
Code Information: Catalog #29158: lot numbers 06FAD300, 06FDA304, 06FAD378, 06FAD386, 06HAD299, 06HAD462, 06HAD485
Reason for Recall: The cardiovascular drape may tear and fray at the reinforced fenestrated trough area during use.
____________________

MedSun Successes – Manufacturers in Action!

Manufacturers have addressed these following issues by: retraining of manufacturing staff; taking corrective actions; issuing Dear Doctor letters to customers; improving labeling, changing suppliers to obtain parts; making current and future design improvements, etc. These have been very conservatively selected – i.e. the manufacturers have told FDA that actions were taken in response to MedSun reports. There are hundreds of other actions that have occurred because the MedSun report added to the trending the manufacturers do – and the manufacturers have taken action on those issues when the problem seems to be occurring higher than the expected rate.

**Please note that the specific manufacturer name is not listed below, and that, in most cases, the action taken is not listed. This data is provided to demonstrate the incredible breadth and scope of the improvement in patient safety that has occurred because of the power of one MedSun report! Where we know that the manufacturer made the action public, we have included it.

CARDIOVASCULAR
•Holter Monitor Analysis System: A holter monitor analysis system waveforms are displayed correctly, but on the printed analysis report form, from which a diagnosis is made, the waveforms are compressed to the point of eliminating the p-wave of the waveform. The p-wave is vital for diagnosing atrio-ventricular block.

•Portable Monitor: A loss of waveform resulted in a drop in the patient’s oxygen saturation for almost one minute. The firm indicates it is notifying consignees of the availability of a new upgraded software version that eliminates the failure mode experienced by the reporting facility.

•Compression Sleeve Connection: There was difficulty in connecting and disconnecting the male and female connectors on a sequential device compression sleeve. In addition, the conductor sometimes pulls completely away from the tubing leaving an open useless hose.
Extracorporeal Membrane Oxygenation (ECMO) Oxygenator: A small amount of blood was noted at the base of an oxygenator and under the outer wrapper. The event occurred during patient transport to the facility. User facility states the device age is one day.

•Warming and Cooling Blankets: Two blankets from the same lot experienced holes and leaks. One was warming and the other one was cooling.

•Pacemaker: manufacturer company representative brought a pacemaker to a surgeon for implantation—it was implanted, and later it was discovered that the device had been recalled many months earlier.

EAR, NOSE, AND THROAT
•Cochlear Implant: Manufacturer failed to inform hospital that a cochlear implant was under recall. The implant was on the hospital shelf, and implanted into a patient.

GASTROINTESTINAL (GI & GU)
•Enteral Polyurethane Feeding Tube: The user facility recently began using this device when the staff noticed a crack at the hub of the device. The crack caused a leak and required early replacement of the tube.

GENERAL HOSPITAL
•Powered Automatic Beds: A safety concern was reported regarding the labeling and readability of the warning for the accessory electrical outlets on two bed models.

•Blood Filters: Numerous MedSun reports cite problems with Rapid Flow Reduction Filters. The filters leaked, even after a previous “fix” that had been instituted.
Blood/Fluid Warmer: A Fluid Warmer was smoking and starting to catch fire.

•Introducers: peel-away introducer sheath did not peel away properly and the physician spent a long time hand-cutting the sheath to get it out of the patient’s body.

•IV Catheter: The hub of a peripheral IV began to leak around the hub end where the catheter emerges.

•IV Catheter: An angio-catheter leaked at the connection of the angio-hub with the catheter.

•Central Venous Catheter Kit: During a central venous catheter insertion, while aspirating, air entered the syringe. A crack was noted in the hub of the needle. Another kit was obtained and an examination of the unused needle from the kit also showed a crack in the needle hub.

•Neonatal PICC Catheter: A minor injury was experienced by a critically ill NICU patient when their dual lumen PICC catheter was noted to be leaking and required immediate removal and replacement. The investigation concluded that the source of the leak was use error and the sales force is re-enforcing the instructions for use (IFU) with their customers.

•IV Set: The check valve on the primary tubing set did not prevent backflow of the secondary fluids into the primary bag.

•IV tubing: An in-line check valve failed to prevent backflow while in use.

•IV Tubing: IV tubing was coming apart at the ‘Y’ of the adaptor.

•IV Tubing: After an IV bag was spiked with the tubing, the tubing would not allow the IV pump to function.

•Needle-Free Injection Site IV tubing: Patient medication was not being infused into the patient and appeared to backflow into the primary IV bag. The firm reemphasized to their customers the importance of fully priming the secondary sets to remove any air from the line, including “tapping” the back-check valve and other components to remove any trapped air, (as stated in the “Instructions for Use”). In addition, the firm stressed the importance of ensuring the primary container is lowered a minimum of 8” when running a secondary infusion.

•Intravascular Administration Set: When opening a disposable IV Fluid Administration Set, the luer lock connection was found to be opened up, when they are normally received connected and tight. The sterility of this product was questioned by the staff.

•Syringe Pump: All infusion pumps from a manufacturer ‘froze up’ at the same time and would not permit any programming to occur. Preventive Maintenance dates for all the pumps were set for a given date by hospital personnel during the initial incoming inspection, one year prior. At or about midnight of that set date, any pump that was turned on would instantly alarm and lockup. The syringe pumps then defaulted to a screen that announced a system failure and then to a screen that displayed “1 Biomed”. If the pump was infusing at midnight, it would continue until complete. However, if an attempt were made to use the pump again, the alarm/lockup would occur. It was determined that the site had programmed the pumps to issue a reminder to users when the preventative maintenance for the pumps was to take place. The software stopped the functioning of the pumps instead of sending the reminder. The manufacturer has sent a letter to customers about this problem.

•Infusion Pump: The pump’s tubing was leaking at the cassette alignment magnet pins.

•Infusion Pump: An over-infusion with the pump is associated with a patient death.

•Infusion Pump: 15cc of air was noted in the lipid syringe and halfway down the tubing of an infant‘s IV Lipids. The lipids had infused too fast and the facility’s clinical engineering department found that the syringe had a dent/defect in it.

•Pain Pump: Pain Pump would not run. There was no direct impact on the patient other than a delay in treatment and increased surgical time.

GENERAL SURGERY
•Malleable retractor: During a valve replacement surgery, the cable on the malleable retractor broke and some of the articulating links fell into the surgical openings in the patient’s chest. The manufacturer sent a memorandum to the reporting customer to remind them of the use, care, and inspection of the device as described in the Instructions for Use. Additional training was also conducted with the sales force to reinforce that the sales reps need to teach physicians proper device inspection.

•Preperitoneal Distension Balloon (PDB) System: The balloon separated from the PDB System while in the patient. The balloon was retrieved and another device was used successfully.

•Steam Integrator: report stated that 6 of 1243 Steam Integrators leaked, thereby spreading ink over the inside of the sterilization pouches and onto the instruments.

IN-VITRO DIAGNOSTICS
•Specimen collection kit for stool Ova Parasites: A non-English speaking patient who was left with a test kit containing two vials of chemical preservative, awaiting stool sample. The patient ingested the contents of vials, one containing polyvinyl chloride and mercuric chloride, and the second vial containing formaldehyde. Many labeling concerns were noted.

NEUROLOGY
•EEG Amplifier: A CTE amplifier was producing mirror imaging of the electroencephalographic signals during monitoring of three patients, resulting in erroneous interpretations of the data.

OBSTETRICS & GYNECOLOGY
•Labor & Delivery Bed: It was noted that the stirrups on a labor and delivery bed fail and allegedly they are easy to move out of position. The reporting MedSun site is currently participating in some customer preference testing. Upon completion of the final validation and verification, the re-designed calf supports will be made available for purchase.

•Vacuum Delivery System: Over the course of a month, problems were noted with 3 separate lots of the vacuums. The fetal extractors were not producing suction and the devices were broken in the package.

RADIOLOGY
•Radiology Table: A technician did not remove the detector plate from under the patient prior to moving the mobile x-ray system away from the bedside. As a result, the patient fell 2-3 feet and landed on the lamb’s wool cover and x-ray detector plate.

•Linear Accelerator: A fiberglass cover fell from a linear accelerator. It landed close to but fortunately did not hit a patient or a health care provider.
Respiratory/Anesthesia

•Adult Respiratory Ventilator Circuit—Dual Heated: Various problems of excessive heating were reported concerning a Dual Heated Adult Respiratory ventilator circuit.

•Ventilator: Excessive corrosion was found on the negative terminal of the main power supply batteries after a burning smell was noted with the device during an operational test. The hospital had notified the firm of this finding and the hospital was provided with a June 2004 Technical Service Bulletin identifying certain batteries that may leak a small amount of acid and corrode the terminals of certain model ventilators. The firm has also issued another Technical Service Bulletin to ensure the replacement of affected batteries and DC modules worldwide.

•Ventilator: Incorrect tidal volume readings.
____________________

FDA Center for Devices and Radiological Health (CDRH) Teams Based on MedSun Reports

External Defibrillators
MedSun received reports describing malfunctions with External Defibrillators (EDs) involving failures of the connecting cables and connectors with “hands-free” configurations. These failures were not discovered during routine functional testing but only when an attempt was made to use them on a patient. A CDRH-cross Center team was organized to evaluate the reported failures. Additional follow-up was made with four of the user facilities that had reported failures via telephone interviews as well as a thorough review of device labeling from various manufacturers. A Safety Tip was prepared entitled, “External Defibrillators Fail to Shock: Means for helping to prevent defibrillator cable and connector malfunctions”.

Bioglue
MedSun reports describe ten pediatric neurosurgical cases where the use of Bioglue® Surgical Adhesive resulted in serious patient outcomes. Bioglue® is a surgical adhesive indicated for use as an adjunct to standard methods of achieving hemostasis in adult patients undergoing open surgical repair of large vessels. It is not expected to be reabsorbed by the body since one of its roles is to strengthen the target tissue. A CDRH-cross Center team was created. The team developed a questionnaire to more fully understand the neurologists’ level of knowledge and experiences with the use of Bioglue and like products. Three neurologists from MedSun sites agreed to answer the questionnaire during telephone interviews. In the meantime, Health Canada has issued a warning that use in neurosurgery can result in adverse events. Two employees from Health Canada are now on the team. The team continues to meet to develop Center-wide solution strategies to these problems.

Electric Hand piece Burns
A MedSun report describes a scenario in which an electric hand piece was being used during a dental procedure, resulting in a patient being severely burned on the upper lip. A review of all adverse event reports in the Center database, a review of the medical literature, and a discussion with FDA scientific reviewers all suggest that electric hand pieces pose a greater risk for burns than traditional air-driven hand pieces. An article about this issue was written and submitted to the Dental Association newsletter. Additionally, a Center team is evaluating solution strategies to the problem.

Implantable Pain Pump Programmer
A MedSun report describes a serious overdose incident. Follow-up revealed that the issue happened when a “bridge bolus” was not properly programmed into the pain pump and that the user may have ignored the pump’s warnings. Discussion with the MedSun site indicated possible Human Factor problems with the screens on the programmer. A CDRH-cross Center team was brought together to evaluate the issue. In addition, the manufacturer provided a demonstration to CDRH on the use of the device in question. The team also visited National Rehabilitation Center for a clinician’s demonstration and a re-creation of the “bridge bolus” incident. The manufacturer met with CDRH in early February 2007 to discuss solutions proposed for the bridge bolus functions. The manufacturer presented at the 2007 Conference for MedSun Representatives about its approach to solving Human Factor issues and about this problem in particular.

Monitor/oximeter and EMI Interference
A MedSun report describes a possible EMI interaction problem with a monitor/oximeter and the hospital’s fire alarms. Follow-up of this event includes posting on DS-X to ascertain if this type of event has occurred in other facilities. Follow-up with the user facility resulted in a request for a MedSun/ECRI visit to the hospital (upon the hospital’s invitation for a 3rd party to visit and evaluate the problem on-site). CDRH’s EMI experts are participating in the MedSun team’s on-going discussions.

Reprocessing of Orthopedic Instruments
MedSun has received several reports indicating problems with accessibility of cleaning, disassembly, and sterilization instructions for orthopedic instruments. There have been reports of instances when instructions for reprocessing orthopedic instruments are not available to the hospitals. A team was assembled to gather detailed information. The team has interviewed several MedSun facilities for their experiences with reprocessing orthopedic instruments. The team is exploring strategies to address the issue.

Transilluminator
Venoscope Transilluminator Recall, which occurred because a MedSun site reported that a neonate was burned by the device. Additionally, the site also tested several other transilluminators and found that the temperatures varied. MedSun has established a team to evaluate the issue, which will include conducting bench testing on various manufacturers’ transillumination devices to determine temperature outputs as well as visual light emissions. Depending on the findings, future regulatory action may be taken.

Human Factors Workgroup
A Center-Wide team has been established to evaluate and implement strategies to ensure the use of Human Factor principles throughout the Total Lifecycle of Medical Devices.
____________________

Surveys/Interviews

Enteral Feeding Connector (Luer Lock)
The Luer Lock group at the FDA is interested in evaluating the types of connectors used for enteral feeding, including those used in conjunction with nasogastric tubes, gastrostomy tubes, and jejunostomy tubes. Email invitations were sent to 150 Lead Representatives at MedSun hospital sites on July 12, 2006. The majority were completed via a secure web-based survey site managed by SSS. Follow up calls and emails were sent to stimulate more responses. This survey was completed in October 2006.
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Interviews & Site Visits

PRISMA Continuous Renal Replacement Device:
MedSun hospitals helped FDA determine the impact and results of the intermediate actions taken by GAMBRO to address problems with its devices until software changes could be developed. GAMBRO developed additional user training and red stickers to be placed on the devices reminding users not to press the ‘continue’ button after an alarm occurs unless the reason for the alarm had been identified and resolved. A total of six interviews were held with MedSun sites, which indicated that GAMBRO had fulfilled the intermediate steps. Additionally, several MedSun sites in the DC area permitted an FDA analyst to observe the device. GAMBRO is installing the newly developed software into customers’ devices. Please continue to report any problems with this device, so FDA may monitor the effectiveness of the software changes.

BAXTER Colleague Volumetric Pumps:
Four MedSun sites were contacted to discuss the impact of potential actions and implications of future steps with regard to reported problems with the Baxter Colleague pumps and the Baxter Syndeo PCA Syringe pumps. The information was very helpful in determining the least burdensome regulatory approach.
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Safety Tips & Articles

•"Pneumatic Tourniquet and Tourniquet Systems."
•"Systems Failures” (displayed in a Swiss Cheese Model, based on a sequence of events, resulting in patient harm with a diagnostic laboratory device).
•"Preventing PICC fractures."
•"Cables and Electrodes Can Burn Patients During MRI."
•"External Defibrillators Fail to Shock: Means for helping to prevent defibrillator cable and connector malfunctions."
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Site Visits to MedSun Hospitals:

•Implantable Pain Pump Demonstration
•Venoscope Transilluminator Demonstration
•HeartNet Interviews and Observations of EP Labs
•Radiology/CT site visit
•Radiology site visit and Operating Room Table Demonstration
•Demonstration of robot-assisted surgical device.
•Observation and discussion of extracorporeal membrane oxygenator equipment in clinical use.
•Observation and discussion about wireless infusion therapy device systems.

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MedSun Adverse Event Reports Related to Home Healthcare Devices

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Jill Marion, Biomedical Engineer, MedSun Project Manager

Introduction
Changes in healthcare have stimulated a significant progression from the hospital environment to the home environment.1 In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home healthcare services from 7,200 agencies.”2 In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home healthcare annually.3

As patients have moved to the use of home healthcare services for recuperation or long-term care, the medical devices necessary for their care have followed them. As a consequence, complex medical devices are more frequently being used in the home, many times under unintended conditions. This in turn has implications for the safe and effective operation of these devices, especially those with sophisticated requirements for proper operation or maintenance.1

Focus on Home Healthcare Device Surveillance
The Food and Drug Administration (FDA) defines home healthcare devices as those used in the home environment by persons who are ill or disabled and who need, or whose care providers need, education or other related healthcare services in order to use or maintain the devices safely and effectively. The FDA is focusing surveillance efforts on two types of devices: devices whose settings are not intuitive (e.g., thermometers, heating pads); and devices that may require additional education, training, and instructions for use in order to ensure the safety and effectiveness of the device, as well as improved patient outcomes (e.g., infusion pumps, ventilators). 1

By means of HomeNet, the newest subnetwork of the Medical Product Safety Network (MedSun), FDA is interested in learning more about device-related problems in the home. HomeNet is a targeted effort focused on identifying, understanding, and solving problems with medical devices used in the home environment. 4

MedSun Reported Adverse Events
To understand the scope of currently reported adverse events involving devices used in the home environment, FDA reviewed MedSun reports submitted between January 1, 2002, and April 27, 2007, which indicated the event reported had occurred in the home. The results of the MedSun search are as follows:

Results by Patient Age (in years):
Age: x=18; Percentage of Reports: 23%
Age: 18Age: x=55; Percentage of Reports: 37%
No age listed; Percentage of Reports: 11%

Results by Patient Sex:
Female; Percentage of Reports: 43%
Male; Percentage of Reports: 44%
Sex not listed; Percentage of Reports: 13%

Top 10 Home Healthcare Devices Reported:
1. Infusion Pump - 30%
2. IV Tubing - 11%
3. Venous Access Device - 11%
4. Feeding Tube - 8%
5. Surgical Hardware - 8%
6. Semi-electric Hospital Bed - 8%
7. Ambulatory Infusion Pump - 8%
8. Oxygen Concentrator - 8%
9. Wheelchair, powered - 4%
10. Ventilator - 4%

The search results include adverse events that resulted from using home healthcare devices; it is important to note, however, that the search also elicited reports that identified adverse events resulting from devices that do not fit the FDA’s definition of a home healthcare device. In these reported incidents, the problem usually began while the patient was in the home (e.g., breast implant rupture, implantable cardioverter defibrillator lead breaking), but did not necessarily involve a device meant for home treatment purposes. While the FDA is interested in both types of reports, HomeNet will focus solely on reports involving the use of home healthcare devices.

Examples of these devices include:
•Infusion pumps
•Ventilators
•Pulse oximeters
•Glucose testing supplies
•Defibrillators
•Enteral feeding systems
•Thermometers
•Heating pads
•Nebulizers
•Wheelchairs
•Apnea monitors
•Durable medical equipment

Case Examples
Case 1: A patient was sent home after surgery with a pain pump to manage postoperative pain. The pump is designed so the patient can remove it by following tips from the surgeon. The patient found resistance while trying to remove the pump catheter. The patient called the manufacturer and was told to call the physician. The patient called the physician’s office and was instructed by the office nurse to pull harder. The patient did as instructed and the pump catheter broke off in the patient’s shoulder. A radiopaque line on the catheter was visible by X-ray, and the retained catheter was surgically removed.

Case 2: A patient was discharged to home on total parenteral nutrition (TPN). The patient was given an infusion pump to administer TPN 16 hours a day. The patient went to a clinic when the central line clotted. Examination of the pump showed it was not administering the TPN to the patient. The patient was admitted to the hospital for hydration and stabilization.

Case 3: A patient was ambulating with a wheeled walker when the left front leg of the walker snapped within the lowest support brace. Neither the support brace nor the clamp securing it to the left front leg was affected. The patient fell, striking her head, and required sutures to close the wound and a CT [computerized tomography] of the head to rule out bleeding.

Conclusion
With the creation of HomeNet, MedSun will strive to enhance patient safety by improving the recognition, reporting, and understanding of device-related events; by utilizing the HomeNet community as an interactive venue in which to validate and understand device-related adverse event signals identified by FDA and HomeNet participants; and by validating reports of device problems in “real time” so that timely interventions to resolve or mitigate problems may ensue.

References:
1. Weick-Brady, M., Lazerow, R. (2006). Medical Devices promoting a safe migration into the home. Home Healthcare Nurses: The Journal for the Home Care and Hospice Professional, 24: 5, 298-304.
2. National Center for Health Statistics. (2004). Home health care patients: Data from the 2000 National Home and Hospice Care Survey. Retrieved August 9, 2007, from http://www.cdc.gov/NCHS/pressroom/04facts/patients.htm.
3. National Association for Home Care & Hospice. (2004). Basic statistics about home care. Retrieved August 9, 2007, from http://www.nahc.org/home.html.
4. Kaufman, D. (2007). HomeNet Information Factsheet. Food and Drug Administration MedSun News.


Additional Information:

Home health care patients: Data from the 2000 National Home and Hospice Care Survey
http://www.cdc.gov/NCHS/pressroom/04facts/patients.htm

Basic statistics about home care
http://www.nahc.org/home.html

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Tubing Misconnection Errors Widely Recognized as Significant Patient Safety Issue

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More than a year after the Joint Commission issued a Sentinel Event Alert about widespread occurrences of tubing and catheter misconnections—errors that can lead to potentially deadly consequences—much attention remains focused on this important patient safety issue.

Earlier this summer, the Wall Street Journal ran a story about the growing concern among the health care industry, Government agencies, and patient safety organizations about tubing misconnection errors. The article referenced the work being done by William Beaumont Hospital, a MedSun site, to address the problem. Beaumont’s work in this area was also presented at the March Conference for MedSun Representatives. A team of staff members made two presentations at the conference: “Tubing and Catheter Misconnections: The Beaumont Experience” and “MedSun-Sponsored Research on Misconnections Involving Medical Devices.” Slides from both presentations are included on the post-conference CD-ROM that was mailed to MedSun Representatives who attended.

The Wall Street Journal article can be accessed through its Web site by searching on “tube misconnections.”

Premier Safety Institute’s newsletter Safety Share also featured an article on the topic¸ “Tubing Misconnections—Better Technology Needed To Eliminate Risk,” in its July issue.

The June issue of MedSun News included a link to an article on luer connector and tubing misconnections written by FDA nurse consultants Beverly Gallauresi, Melissa Eakle, and Audrey Morrison.

To learn more about tubing misconnection error, see the next two articles in this newsletter edition.

Additional Information:

Wall Street Journal
http://online.wsj.com/public/us

Tubing Misconnections—Better Technology Needed To Eliminate Risk
http://www.premierinc.com/quality-safety/tools-services/safety/safety-share/07-07-full-txt.jsp#story-02

Safe Practices in Patient Care
http://www.safe-practices.org/

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A Look at MedSun’s Enteral Feeding Misconnections Survey

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Jill Marion, Biomedical Engineer, MedSun Project Manager
Jay Crowley, Senior Advisor for Patient Safety
Food and Drug Administration


Background
Many types of tubing misconnections can occur with a variety of medical devices in the clinical setting. Since misconnections involve direct routes into the body, they often result in serious injury or death. One common mode of misconnection is with Luer locks, connectors and fittings, which are commonly used components that can easily be connected, and also mistakenly misconnected, to many different medical devices.1,2,3

One frequent misconnection of Luer fittings occurs with enteral feeding systems. Because these misconnections are thought to be grossly underreported, the actual number of enteral feeding system misconnections that occur nationwide is unknown.1,4

The enteral feeding system is the entire apparatus, including the enteral nutrition formula container, the delivery tubing, and the enteral tube itself, along with any connectors, pumps, or syringes that may connect with the system. Three types of connectors commonly used in the enteral feeding system are the enteral connector (sometimes called the Christmas tree connector), the Luer slip connector, and the Luer lock connector.

Medical misconnections are a well-known issue, with enteral misconnections cited in the literature as far back as 1972, in a report of inadvertent intravenous (IV) administration of breast milk.6 The Food and Drug Administration (FDA) has received adverse event reports documenting many different types of enteral misconnections, including the mistaken misconnection of enteral feeding tubes to IV lines and tracheal tube pilot balloons.2 In addition, other health organizations have received reports of misconnections of enteral feeding systems to device components such as central venous lines, peripheral catheters, PICC lines, hemodialysis lines, parenteral lines, oxygen cannulas, and inflation ports of the tracheal cuff.5

Examples of Reported Misconnections

•A confused patient inadvertently connected his enteral set to a needle-free injection site.
•A patient’s enteral nutrition line was misconnected to a central venous line.
•Pediatric enteral feeding solution was infused into the patient’s peripheral venous catheter.
•Rather than a dedicated enteral pump, IV tubing and an IV pump were used to administer enteral feedings, with subsequent enteral feeding administered through a central venous device.

Survey Methodology
In an effort to collect information on the frequency of medical device misconnections and to understand the severity of such events, the FDA and the American Society of Parenteral and Enteral Nutrition (ASPEN) worked collaboratively to develop a survey for distribution in 2006 to FDA’s Medical Product Safety Network (MedSun) participant hospitals. The survey was sent to 150 MedSun facilities that fit the original criteria of 200 beds or more. The survey comprised approximately 10 questions regarding use of enteral systems and detected misconnections experienced. The survey questions aimed to determine the following:

•Misconnections experienced at the hospital
•Potential for misconnections in the hospital
•Internal hospital procedures to decrease the potential for misconnections to occur.
(Survey cleared through the Office of Management and Budget [OMB] under the generic Rapid Response Survey Clearance: OMB No. 0910-0500)

Survey Results
Of the 150 facilities contacted, 111 (74 percent) of them responded with 135 surveys. Note that not all survey respondents answered every question, and some facilities submitted more than one completed survey.

The survey questions and responses follow.
•What type of connectors on enteral feeding sets is used in your practice?
Connector Type: Enteral; Responses: 97
Connector Type: Luer; Responses: 19
Other; Responses: 19
Total Responses 135

•Do you use extension sets to attach the enteral feeding set to the feeding tube?
Use of Extension Set:
Yes; Responses: 25
No; Responses: 91
Sometimes; Responses: 15
Don't Know; Responses: 4
Total Responses: 135

•If you use extension sets to attach the enteral feeding set to the feeding tube, do the extension sets have different fittings?
Different Fittings on Extension Sets:
Yes; Responses: 13
No; Responses: 16
Sometimes; Responses: 11
Don't Know; Responses: 10
Total Responses: 50

•Does the use of connector type vary by location/environment, e.g., in the ICU?
Use of Variable Connector Type:
Yes; Responses: 13
No; Responses: 101
Don't Know; Responses: 21
Total Responses: 135

•If yes, how and why?
The following are representative samples of responses regarding determination of the type of connector used:

-Depends on what type of feeding tube is being used or who placed it. Pediatric patients that graduated to the adult floor usually have a different type of G-tube [gastrostomy tube] that has a unique connection. People from other hospitals have different brands of G-tubes and J-tubes [jejuneostomy tubes]. GI [gastrointestinal] procedures place different types of tubes for enteral feeding that sometimes require different connections to fit the enteral feed bags.
-Each department orders [its] own supplies, so there is no standard connector used.
-Depends on the age/type of patient. For babies, a syringe pump is used since the feeding volume is so small.
-Depends on the experience of the nurse.

•If you currently use Luer fittings for enteral feeding, what barriers or concerns do you think your organization or practitioners would have switching to the use of the enteral connectors?
The following are representative of responses received:

-Concerned with locking ability of enteral connectors.
-Enteral connectors not available for purchase from all distributors.
-It is too hard to standardize all of the parts to enteral connectors, since the clinicians are so accustomed to using Luer connectors.
-Concerned with finding an enteral connector that would accommodate the oral syringes used for infants.
-Enteral connectors tend to “stretch” the opening of the tube over time and thus the adaptor slips out of the tube.
-The PSI [pound-force per square inch] of the pump and small size of the feeding tube cause the enteral fitting to “pop off.”
-Babies can easily pull off the enteral connectors, but they can’t pull apart a Luer lock connector.
-Low-volume continuous infusion feeding pumps are currently not available in the U.S. Therefore, low-volume feedings must be delivered utilizing a medication syringe pump and medication syringe. Medication pumps are currently not calibrated for use with oral syringes. Enteral connectors split the hubs or pop off the hubs of many of the currently available gastric feeding tubes for neonates. Using oral-only feeding tubes, with oral-only extension sets, and oral-only syringes is not currently an option for low-volume infusions (especially breast milk) because of the infusion device limitation.
-Not enough devices are compatible with enteral connections.
-The cost of enteral connections is too high.

•Do you currently use any type of label or coding to differentiate feeding tubes or sets from other systems with Luer fittings?
Use of Coding to Differentiate Sets:
Yes; Responses: 56
No; Responses: 58
Don't Know; Responses: 21
Total Responses: 135

•Has your organization ever experienced a misconnection between an enteral system and another system?
Organizational Experience with Misconnections:
Yes; Responses: 19
No; Responses: 69
Don't Know; Responses: 47
Total Responses: 135

•What actions has your institution taken to address potential misconnections between incompatible systems?

The following are summaries of the responses received. (Note that these are suggestions received from MedSun hospitals and are not necessarily supported or promoted by the FDA.)

–Labeled the tubes (i.e., NOT FOR IV USE on feeding tube or ENTERAL FEEDINGS ONLY on enteral tubes).
–Color coded the tubes.
–Implemented user education/ RN inservicing/discussing JCAHO [Joint Commission] Sentinel Alerts/ Discussing ISMP [Institute for Safe Medication Practices] newsletters.
–Switched to all enteral connections.
–Devised a system to require user to trace tube back to its origin.
–Switched to using only oral syringes since they aren’t compatible with IV lines [although adapters can be used on the IV lines that would allow for oral syringe compatibility].
–Made sure products are incompatible if not used for the purpose [for which] they are purchased.
–Switched to a neonatal feeding system that doesn’t allow for IV misconnections.

•About what percentage of your patients across all clinical specialty areas have both a vascular access device (i.e., catheter) and an enteral feeding tube?
Percentage of Patients With Vascular Access Device and Enteral Feeding Tube (%):
0–20%; Responses: 43
21–40%; Responses: 15
41–60%; Responses: 18
61–80%; Responses: 10
81–100%; Responses: 17
Total Responses = 103

•Does this percentage vary by unit, e.g., ICU, Med-Surg?
Variation of Multiple Connection Devices by Unit:
Yes; Responses: 77
No; Responses: 14
Don’t know; Responses: 43
Total Responses: 134

•Do you send patients home with enteral feeding?
Patients Are Sent Home With Enteral Feeding:
Yes; Responses: 96
No; Responses: 20
Don’t know; Responses: 19
Total Responses: 135

•If yes, what connectors are used?
Type of Connectors Used at Home:
Luer; Responses: 9
Enteral; Responses: 79
Don't know; Responses: 17
Total Responses: 105

The survey results indicate that enteral misconnections continue to occur, and that there is a large potential for these misconnections to occur in various parts of hospitals. Several hospitals have taken internal steps to prevent misconnections, and many health organizations are currently working together to take action to prevent misconnections and keep patients safe.

Preventing Misconnections
Many health organizations have taken steps to raise awareness of medical misconnections.

The FDA wrote an article with a list of precautions, published in Nursing 2005, that can be taken by clinical staff in order to promote the prevention of misconnections.3

•Educate all clinical staff who use Luer devices about the hazards of misconnecting tubing and devices.

•Teach clinical staff to first carefully inspect and then follow the proper connector sequence when connecting tubing and device components.

•Read and follow the equipment manufacturers’ recommendations and precautions, especially regarding compatibility with other devices.

•Don’t modify IV or feeding devices because doing so may compromise the safety features built into their design.

•Tell patients they must ask clinical staff for help when they need to disconnect and reconnect equipment. A patient or family member could easily connect the wrong devices.

•Report known or suspected misconnections to the appropriate person in your facility and to the FDA through its MedWatch reporting program.

•At your facility, join committees that are responsible for choosing products. Then encourage these committees to choose safety-designed devices to eliminate or reduce the risk of misconnections.3

Additionally, FDA wrote an article on the topic of Luer misconnections that was published in Safe Practices in Patient Care. Free Continuing Education credits are offered after reading this article. The article can be accessed at www.safe-practices.org.7

The Association for the Advancement of Medical Instrumentation (AAMI) developed a standard in 1996 (ANSI/AAMI ID54:1996/(R) 2001 “Enteral feeding set adapters and connectors”)2,8 that called for the elimination of adapters and connectors that are compatible with female Luer lock rigid connectors. A positive result from the creation of this AAMI standard was the adoption by some device manufacturers of a unique enteral connector at the end of the enteral feeding sets. In addition, a human factors engineering guidance (HE-74, Human factors design process for medical devices) has been published by AAMI. This document can be used to test connectivity and misconnection potential between devices in a clinical setting.8

A multifaceted workgroup was formed in 2006 to address the problem of enteral feeding system misconnections. Participants include members from FDA, ASPEN, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), ISMP, ECRI Institute, the American Nurses Association (ANA), the American Hospital Association (AHA), United States Pharmacopeia (USP), and the U.S. Department of Veterans Affairs, as well as various clinical and industrial representatives. In addition, the International Standards Organization (ISO) has formed a joint workgroup to consider problems with medical device misconnections.

Premier Safety Inc., the purchasing alliance of many hospitals nationwide, continues to educate device manufacturers to encourage the design of enteral systems that do not allow for Luer misconnections.

MedSun contracted with the Beaumont Services Company’s Clinical Engineering Department and William Beaumont Hospital's Pediatric Intensive Care Unit to develop several educational tools to help hospitals deal with the complex issues of Luer misconnections, and to increase health care professionals’ awareness of misconnections and their impact on patient safety. These tools were distributed to MedSun facilities and will be made available on the soon to be released public MedSun site.

The reported misconnection examples listed in this article, as well as the results of the MedSun survey, show the many different ways misconnections can occur. The FDA is working closely with many health organizations to increase awareness of misconnections as well as to promote the prevention of misconnections. As FDA gains information about the progress these health organizations are making regarding the prevention of misconnections, the information will be made publicly available in order to achieve the common goal of ensuring patient safety.

References
1. Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence, Issue 36, April 3, 2006, http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm; accessed on April 14, 2007.
2. ISMP Medication Safety Alert. Problems Persist With Life-Threatening Tubing Misconnections, June 17, 2004, http://www.ismp.org/newsletters/acutecare/articles/20040617.asp; accessed on April 22, 2007.
3. Eakle, Melissa, R.N., M.B.A., M.S.N., Gallauresi, Beverly Albrecht, R.N., B.S., M.P.H., Morrison, Audrey, R.N. Luer-lock Misconnects Can Be Deadly, Nursing 2005, 35 (9), Sep 2005, p. 73.
4. FDA Patient Safety News. Show #31, Sep 2004; Show #20, Oct 2003; Show #46, Dec 2005.
5. Crowley, Jay. The Risks of Misconnections Luer Fittings and Enteral Feedings; presented May 16, 2006 to U.S. Pharmacopeia’s Safe Medication Use Expert Committee.
6. Wallace, J.R., Payne, R.W., Mack, A.J. Inadvertent Intravenous Breast Milk, Lancet 1972 Jun 10:1(7763): 1264-6.
7. Gallauresi, Beverly, R.N., B.S., M.P.H., Eakle, Melissa, R.N., M.B.A., M.S.N., Morrison, Audrey, R.N., Misconnections Between Medical Devices With Luer Connectors: Under-recognized but Potentially Fatal Events in Clinical Practice, Safe Practices in Patient Care, July 2007, Vol. 3, No. 2.
8. Association for the Advancement of Medical Instrumentation, http://www.aami.org/; accessed on July 16, 2007.

Additional Information:

Tubing Misconnections—A Persistent and Potentially Deadly Occurrence
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm

ISMP Medication Safety Alert. Problems Persist With Life-Threatening Tubing Misconnections
http://www.ismp.org/newsletters/acutecare/articles/20040617.asp

Association for the Advancement of Medical Instrumentation
http://www.aami.org/

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Epidural and Intravenous Infusion Mix-Ups

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From ISMP Medication Safety Alert!® Nurse Advise-ERR
July 2007, Volume 5, Issue 7
©2007 Institute for Safe Medication Practices (ISMP)

A nurse accidentally infused potassium chloride injection by the epidural route into a postoperative patient with hypokalemia. The nurse intended to connect the IV tubing from the potassium minibag (20 mEq in 50 mL) to the maintenance IV infusion line via a Y-site port. Instead, she connected the potassium bag to a Y-site port located on the patient’s epidural line through which fentanyl and bupivacaine was infusing. The patient received the entire contents of the minibag over 2 hours, after which the nurse disconnected the minibag. Shortly thereafter, an anesthesiologist discontinued the epidural line. Later, the nurse returned to the patient’s room to hang another dose of potassium chloride and realized that she must have connected the prior infusion to the epidural tubing. The anesthesiologist and surgeon were immediately notified. Fortunately, the patient developed no symptoms during or after the potassium infusion.

At first glance, the underlying cause of this error may seem clear—using tubing with a Y-site access port for an epidural infusion. However, examining why this error occurred in a facility that typically used special epidural tubing without access ports led to the discovery of additional causal factors.

Standard procedures not followed:
For patients with epidural infusions in place for analgesia during the immediate postoperative period, post-anesthesia care unit (PACU) staff typically attached special epidural tubing without an access port. Standard procedures were not followed in this case. The patient’s surgery occurred on a weekend, and the patient had been recovered in ICU, not PACU. While in ICU, the epidural catheter was capped because it started leaking. Thus, the patient was transferred to a medical-surgical unit with a capped epidural.

Faulty procedure and tubing:
Usually, when staff nurses receive a patient in the medical-surgical unit with an epidural infusion, the special tubing has already been attached. In fact, before this error, a patient had never come to the unit with a capped epidural catheter. When the patient complained of pain, the nurses decided to start the epidural analgesic per the standing orders that had remained on the chart. In preparation, they read a recently written policy and procedure for epidural analgesia which, unfortunately, did not mention the need for special tubing without access ports. In fact, epidural tubing was not available in the unit’s supplies. Thus, regular IV tubing had been used to connect the epidural analgesia, allowing the potassium infusion to be accidentally connected to the epidural infusion port.

Double-checking policy not known:
The hospital had a rigorous policy regarding independent double-checks for IV potassium infusions in concentrations greater than 60 mEq/L. If the policy had been followed, the doublecheck would have required the nurse to show a colleague at the bedside exactly where she had attached the IV potassium infusion. However, the double-check policy had just been implemented a few weeks prior to the error, and some nurses were unfamiliar with its scope. Most of the nurses thought the policy required two staff to double-check the medication label and dose against a patient’s medication administration record (MAR), but they were not aware that they also needed to check pump settings and trace the tubing to the site of injection.

See Check It Out! [below] for recommendations to reduce the risk of mix-ups between epidural and IV routes of administration.
_________

Check It Out! Consider the following suggestions to help avoid epidural and intravenous infusion mix-ups.

•Use special tubing. Only use special epidural tubing without injection ports for epidural infusions. Use of this tubing with restrictive access is a key error-prevention strategy that should be clearly described in all policies, procedures, and standard order sets related to epidural infusions. Place a neon "Epidural" sticker on the tubing (which is often included with epidural tubing).

•Build redundancy. Require an independent double-check of all epidural infusions at the bedside, and require nurses to trace the tubing from the source (infusion) to the insertion site (port) to verify the line attachment.

•Communicate. Establish a standard communication process for use when transferring surgical patients between preoperative, intraoperative, and postoperative care settings. Unusual circumstances, such as capped epidural catheters, should be described fully. See Special Announcements [on page 2 of this issue] for information about a tool kit to help with critical handoffs of surgical patients.

•Restrict privileges. Epidural infusions should only be started by practitioners who demonstrate ongoing competency (typically professional staff from anesthesia, PACU, labor and delivery, and certain critical care units).

•Segregate pumps. Place general IV pumps and epidural infusion pumps on opposite sides of the patient's bed to separate the two infusion systems. Use a different make or model of pump for epidural infusions to make them look different from IV pumps. Label the pump, "Epidural.” Avoid using dual-channel pumps for simultaneous administration of IV and epidural infusions.

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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:
Findings of a study by J.L. Tri, M.S.E.E.; R.P. Severson, CBET; L.K. Hyberger, M.A., CCRC; and D.L. Hayes, M.D., published in Mayo Clinic Proceedings [82(3):282–285], showed that no problems were found during 300 tests of two different telephone technologies from different carriers. From February through June 2006, the cell or mobile phones were switched on near 192 medical devices in 75 patient rooms. The incidence of clinically important interferences was 0 percent.

In light of these findings, has your facility changed the cell phone policy? Would you be willing to share these changes?

Comment:
The Mayo Clinic study is a good one for very specific conditions. It does not, however, address the cause–effect relationship between unintentional radio frequency (RF) sources such as cellular phones and handheld music devices, and medical instruments operating within short distances. Several factors influence electromagnetic interference (EMI), including the power setting of the cellular phone (which varies and is not under user control), the transmission platform, the physical layout of the patient room and building, the distance separating the RF source and the medical instrument, and, very importantly, the medical instrument’s wiring harness and its enclosure design. For example, dialysis machines with long wiring harnesses have demonstrated higher sensitivity to EMI than have small electronic thermometers. In addition, the mode of failure is important: a change in the operation of the instrument, which is not readily detectable by the user, is more critical than a change that generates an alarm or an obvious malfunction and then self-corrects.

The effects of EMI on medical instrument performance have been documented In multi-institution studies.* One of the studies—conducted in the clinical environment of a hospital acute care area after obtaining documented consent from patients—showed that under certain conditions related to power, platform, distance, and medical instrument, EMI problems can be replicated and mitigated by appropriate education, policy, and procedures.

Without a study that includes all the different transmission platforms and combinations of medical instruments used in the clinical environment, the complete relaxation of a cell phone ban is unsafe. Many years ago, in the absence of good clinical studies, we banned cell phone use in our hospital. However, after performing a study involving real-world clinical conditions, we realized that all the interference effects occurred within a 3-foot radius of the medical device or the “sphere of risk.” As a result, 5 years ago, we modified our policy to prohibit the use of cellular phones within the "sphere of risk" in specific locations where the density of medical instruments is higher and where EMI problems were previously observed, namely the dialysis unit, catheterization lab, and intensive care unit. This policy is still in place.

Comment:
We have relaxed our cell phone policy over the last couple of years. In critical care areas, cell phones can only be used in the waiting areas. As for other areas in the facility, we maintain a 3-foot policy, meaning that one must be at least 3 feet away from a medical device when using a cell phone. We also require that users of two-way radios keep a distance of 15 feet from medical equipment.

Comment:
From FDA: FDA does not have specific recommendations on the use of cell phones in hospitals. Based on circumstances, each hospital must assess its own risk and manage its electromagnetic environment. "FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities."

*See “Safe Use of Cellular Telephones in Hospitals: Fundamental Principles and Case Studies,” by T. Cohen, M.S. CCE; W.S. Ellis, Ph.D., M.D.; J.J. Morrissey, Ph.D.; C. Bakuzonis, M.Eng., CCE; Y. David, PE, Ed.D., CCE; W.D. Paperman, CE, in the Journal of Healthcare Information Management 19(4): 38–48, http://www.himss.org/ASP/index.asp.


Additional Information:

FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities
http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/default.htm

Additional information on this topic is available at
http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/default.htm

Safe Use of Cellular Telephones in Hospitals: Fundamental Principles and Case Studies
http://www.himss.org/ASP/index.asp

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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 June 1 through June 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: Laryngoscope, Bullard Catalog# LARS-A
Manfacturer: ACMI Corporation
Problem: A trauma patient complained of a sore throat after a nasal fracture reduction procedure. Examination of the patient revealed that a plastic laryngoscope blade extender tip had been left in the patient when the laryngoscope was removed. Examination of the laryngoscope revealed that the plastic extender can be difficult to attach, and, if not properly attached, can unintentionally become disconnected from the device.


CARDIOVASCULAR
Device: Automated External Defibrillator, Powerheart AED Model# 9300E-001
Manfacturer: Cardiac Science Corporation
Problem: The first responders (Police) received a 911 call regarding a person who was having cardiac arrest. Having arrived at the scene prior to the paramedics, the first responders attached their automated external defibrillator (AED) to the patient. The responder opened the lid, which turns the AED on and readies it for use. The “Rescue Ready” light was green, which indicates that the AED is in working order. The electrodes were placed on the patient and the voice/text prompted them “Do Not Touch Patient. Analyzing Rhythm. ” Normally, the next phrase is “Shock Advised. Charging. Stand Clear. ” However, instead, the message that was given was, “Service Required.” (The printout from the AED shows that the patient was in ventricular fibrillation prior to the “Service Required” statement. At this point, the ambulance crew had arrived, and the lid of the nonfunctioning AED was closed, and the paramedics attached their AED. The patient received one shock, was converted to sinus tachycardia, and was transported to the hospital. The patient remains hospitalized at this time. The outside agency (owners of the malfunctioning AED) requested that this reporter complete the MedWatch report. Cardiac Science was notified of this occurrence by the outside agency and its response was to send the AED to the company for evaluation. The outside agency will send Cardiac Science the AED and has requested that the findings of the evaluation be sent to the agency.


Device: Warming System, Blanket,
Level 1 EQ Equator 5000 Convective Warmer Model# EQ 5000
Manfacturer: Smith’s Medical
Problem: The EQ 5000 convective blanket warmer was in use when a burning odor was noted by staff members, followed by a cloud of smoke. The unit was turned off and removed from the surgical room. Upon inspection, the Biomedical Department staff noted that the filter did not contain a gasket, an omission which allowed the plastic filter case to be in direct contact with the heater element, therefore causing it to melt. Later, in a discussion with the manufacturer, staffed learned that the filter parts ordering process requires that the two parts (gasket and filter) be ordered separately for replacement of the filter assembly. These parts have to be assembled together, prior to installation. We suggested to Smiths Medical that the filter be sold as one assembly, which would eliminate any chance of having the filter installed without a gasket and prevent any similar incidents in the future. This issue was discussed in detail with the Smiths Medical Product Manager. As a result, we were provided with a new operator manual, which contains more detailed information on the filter replacement than did the old manual we were using for this device. In addition, we were assured that in the future the device will be sold with the gasket and filter already assembled.


Device: Warmer, Patient,
Bair Hugger Model# 500/OR
Manfacturer: Arizant Healthcare Inc.
Problem: The Bair Hugger was applied for AAA (abdominal aortic aneurysm) surgery. Two hours into the procedure bleeding was noted, and the patient’s temperature was 32.4. The Bair Hugger was found to be providing room-temperature (cool) air.


Device: Central Venous Catheter, Cordis Introducer Model# SSS 8.5 Fr 7007BF85 SSS 7008BF09 9 Fr
Manfacturer: Edwards Lifesciences
Problem: There are multiple concerns with the Edwards central line kits, particularly with the Cordis (9 Fr introducer). They include: (1) the long needle used to puncture the vein is extremely flimsy and frequently bends or breaks when trying to get it under a patient with a thick clavicle; (2) the catheter does not directly interface with the transvenous pacing wires made by the same manufacturer; and (3) the introducer catheter itself is extremely flimsy and prone to kinking and shearing of the tip when the needle is reinserted.


GASTROENTEROLOGY/UROLOGY
Device: Gastroscope, GIF Model# Q180
Manfacturer: Olympus America Inc., Diagnostics Systems Group
Problem: While performing an EGD (esophagogastroduodenoscopy) on a patient, the doctor commented that there appeared to be a small, black, round object in the patient. He noticed the black object after the biopsy forceps were passed with the scope. He continued to take the biopsy bite, retrieve the specimen, and complete the procedure. The black object was identified as the distal tip ring of the scope. The physician said the ring would come out when the patient had a bowel movement. The scope was given to the endoscopy technician, who sent it away for repair. The scope is routinely hand-cleaned, put through a leak test, run through a sterilization processor, and hung to dry before being used again. It is used between one and three times per day. The distal tip ring is not removed during the cleaning process.


Device: Stone Extractor, Tipless, Nitinol Model# NTSED-024115-UD Lot# U1557727
Manfacturer: Cook Urological Incorporated
Problem: We returned two stone extractors to the manufacturer for evaluation after experiencing difficulty during two different procedures. In both cases, surgeons were unable to get the extractor to close. Cook representatives responded that inadequate adhesion was a potential cause for this failure, and they are investigating the issue further.


Device: Gastric Band, Adjustable, BioEnterics LAP-BAND Catalog# B-2220, Size – 10 cm
Manfacturer: INAMED,
A Subsidiary of Allergan, Inc.
Problem: The LAP-BAND was placed last year. Initially, the band was effective, and the patient was demonstrating good weight loss. Recently, the fluid in the LAP-BAND system has been slowly leaking from somewhere in the system, with no liquid in the band on rechecks. The physician felt the likely site of leaking was at the port. The patient was taken to the operating room for replacement. Upon mobilizing the port from its facial attachment, it was brought up into the wound. A clamp was used to clamp the tubing distal to the port; then, using a huber needle, the port was accessed and saline was injected. A leak was immediately identified in the port at the junction between the rubber dome and the white plastic portion of the port. It appeared that the port was leaking in this location. No other areas of leakage were identified. The port was removed and replaced with a new port. The new port was then accessed with a huber needle, saline was injected, and it was determined that the port was watertight and holding the fluid with no problems.


GENERAL SURGERY
Device: Sponge Counter, Electronic Safety-Sponge System Model# N10410
Other Device # Software Version 1.8.8.0
Manfacturer: SurgiCount Medical, Inc.
Problem: We have had numerous problems with the SurgiCount sponge counters. In this particular incident, staff reported that the screen "froze and became scrambled." Upon rebooting the device, the count and report for this case were lost. A staff member was able to continue the case using a manual count. The most common problems with this device have been that the display freezes and becomes unresponsive to all controls. In most cases, the device can be rebooted to solve the problem. In some cases, staff members reported the count in the device indicated an inaccurate sponge count, which suggested that sponges were never used during the case. A manual count is always maintained as a backup, regardless of whether a sponge counter is used, due to the unreliability of devices; the discrepancies oftentimes result in more work for staff members. We have had at least 21 separate cases of device malfunction, which have ranged from freezing during use, to not scanning appropriately, to screens’ becoming unreadable or scrambled, to fields’ overlapping. These problems have resulted in delays during surgery and questionable/inaccurate sponge counts. The manufacturer representatives stated that they were working on new software for this device, and that the new version is scheduled to be released sometime later this month. Some devices have been sent back to the manufacturer, but mostly for repair of mechanical damage. The software glitches seem to be transient and can usually be resolved by rebooting the system.


Device: Table, Surgical, ALPHASTAR
Manfacturer: MAQUET, Inc.
Problem: The head of the bed was pushed in prior to the patient's arrival in the operating room. Upon turning the bed for positioning, a staff member pulled and turned the head of the bed. The head of the bed came out of the bed, and the patient's head hyperextended and flexed forward. A cervical collar was placed on the patient. Portable X-rays were taken of the patient's neck. This table uses a hand-operated crank to lock the head into position. If the handle is not cranked hard enough, the locking mechanisms may not be safely initiated. However, locking/tightening of the head may be difficult for some individuals who are less physically strong. Due to the fact that this is a repeated problem in our facility, other types of beds are being considered for purchase.


Device(s): Dissector System,SPACEMAKER PLUS Lot# U7C38 Catalog# (01)00613830153992 Other Device# (17)090331 (10)U7C38; Trocar, PediPort Lot# P4J1118 and P7A015 Catalog# (01)00613830124794 Other Device# (17)120131 and (17)090930
Manfacturer: United States Surgical Corporation
Problem: The patient was scheduled for a bilateral laparoscopic inguinal herniorrhaphy. A SPACEMAKER PLUS was being used. The balloon on the SPACEMAKER PLUS broke while the trocar was being pulled out. Also, the PediPort from the laparoscopic herniorrhaphy pack would not open. The surgeon states that the PediPorts will not open and that he has had at least 10 of these ports fail in a similar way. All three ports that he tried on this patient failed. He states that he will not use this port again.


LABORATORY/DIAGNOSTIC TESTS
Device: Analyzer, Chemistry, Bayer ADVIA Centaur Immunoassay System
Manfacturer: Siemens Medical Solutions Diagnostics
Problem: There have been six reports of incorrect troponin values released. The incorrect values were obtained using the same chemistry analyzer. (1) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.07 ng/ml. The repeat on another analyzer was 0.03 ng/ml. (2) Troponin imprecision on the Bayer Centaur resulted in reporting of incorrect troponin values of 0.08 ng/ml and 0.39 ng/ml. The repeat on another analyzer was 0.02 ng/ml. (3) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.08 ng/ml. The repeat on another analyzer was 0.02 ng/ml. (4) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.30 ng/ml. The repeat on another analyzer was 0.13. ng/ml. (5) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.15 ng/ml. The repeat on another analyzer was 0.09 ng/ml. (6) Troponin imprecision on the Bayer Centaur resulted in reporting of incorrect troponin values of 0.028 ng/ml and 0.09 ng/ml. The repeat on another analyzer was <0.02 ng/ml. In all six cases, the corrected report was called to the RN. The results were corrected in the computer, with a note of explanation. There was no patient intervention based on the incorrect laboratory results. The company was called, and service representatives came to fix the problem. They think that air was trapped in the lines after the daily cleaning. We do not know how that occurred or how to prevent it in the future. The quality control for the troponins worked, and the technician had no reason to doubt the operation of the instrument for the troponin assay.


Device: Sweat Collection System, Macroduct Model# 3700
Manfacturer: Wescor, Inc.
Problem: The patient is a newborn who was seen for a sweat chloride test. The patient sustained an injury to his arm where the pilogel disc/electrode was placed to perform the test; however, the cause is unknown. This reaction was discovered after the 5-minute sweat stimulation was completed and the pilogel disc was removed. The patient was evaluated in the Emergency Department. It was noted that the patient had a 2–3 mm lesion that was dark in color and appeared to be consistent with a burn. The Macroduct system was evaluated by the Biomedical Department and determined to operate as designed.


Device: Glucose Test Strips, MediSense Precision PCx
Manfacturer: Abbott Laboratories Diagnostic Division
Problem: The facility had used MediSense Precision PCx strips for point-of-care glucose testing for many years. The Neonatal Intensive Care Unit (NICU) was plagued with requests from the term Nurseries and Labor and Delivery to retest infants' blood sugars using our i-STAT device. The i-STAT results were almost always significantly higher than the PCx readings. In April 2007, we began using MediSense Precision PCx Plus strips (AKA: Gold strips). The result was an approximate 75 percent drop in the number of i-STAT tests being done in the NICU!


NEUROLOGY
Device: Head Rest, Cranial Support, Mayfield Modified Skull Clamp With Skull Pins
Manfacturer: Integra LifeSciences Corporation
Problem: During the preparation stage, the patient was placed in the Mayfield head holder by the neurosurgical resident. The left-sided pin was tightened to a torque of 60 pounds, which is standard. The patient was being positioned by the resident and the physician assistant; the pin slipped and a 1.5 cm laceration of the scalp resulted on the left temporal region. The resident sutured the laceration, and notifications were sent out. The C-clamp and pins for the Mayfield were replaced with another set. The C-clamp and pins were segregated. This was a loaner set, in which the torque screws were located on the two pin holders as well as on the left side of the C-clamp. The neurological director requested that an extra staff member be available at the head of the table with the anesthesiologist to prevent this event from reoccurring.


ORTHOPEDICS
Device(s): Pump, Arthroscopic, Continuous Wave III Model# AR-6475; Tubing, Arthroscopic Pump
Model# AR-6410
Manfacturer: Arthrex Arthroscopy Instruments, Inc.
Problem: During a right-knee arthroscopy, the Arthrex water pump began alarming "Pressure Fault." The circulating nurse stopped the pump and began looking at the troubleshooting procedure. The nurse looked at the fluid and it was adequate; she then took off the suction tubing from the canister and tried to restart the pump. The pump spun very fast and again stated "Pressure Fault." The nurse then reconnected the suction because fluid was coming out of the knee from the field. All the clamps along the tubing were checked and all were found to be open. The pump was restarted, and again it spun very fast. The pump was stopped again. At this point, the surgeon stated that the patient's thigh was very hard, and that he was having difficulty bending the knee. The scope was removed from the knee, and the tourniquet was released after being inflated for only 24 minutes. The surgeon then applied pressure to try to reduce the swelling. The nurse continued to troubleshoot the pump by requesting a new Arthrex pump. The tubing was changed over to the new machine and restarted. After 1 minute, the same "Pressure Fault" error occurred; this time, however, the scope was not in the knee. The tubing was changed and the pump was restarted. Everything seemed to check out and work correctly, and the case was completed. Unfortunately, the original tubing used was discarded after the case was finished. This is at least the third time a problem of this nature has occurred at our facility. This system requires that the exact setup steps be followed precisely in the correct order for the pump to function properly. If the balloon inside the cylinder is inadvertently collapsed, pressure changes will not be correctly detected. The balloon may become collapsed by leaving the tubing clamps on when starting the pump, or by spiking the fluid bags before inserting the disposable pressure-sensing components. If the tubing is disconnected and then reconnected, or if the same tubing is used on a different machine, this will not repair the pressure calibration problem.

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Updated September 1, 2007

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