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U.S. Department of Health and Human Services

MedSun: Newsletter #31, December 2008

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Newsletter #31, December 2008

Articles

FDA Preliminary Public Health Notification: Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change

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FDA Medical Device Safety Website

If you are seeing or have seen issues with your medical device since the recent switch to Daylight Savings Time, please read the following article, which offers recommendations to address potential issues.

Additional Information:

Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064705.htm

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FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

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FDA Medical Device Safety Website

Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. This notification includes several recommendations on how to help prevent these problems. For example, obtain specialized training for each mesh placement technique, and watch for complications, especially those associated with the tools used in transvaginal placement.

Additional Information:

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. FDA Medical Device Safety Website. October 20, 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

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FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

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FDA Press Release
As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.
OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.
To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

Additional Information:

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer. FDA Press Release. November 6, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116977.htm

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LabNet

2009 National Patient Safety Goals: Laboratory Services Program

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The Joint Commission (TJC)

2009 National Patient Safety Goals for the Laboratory Services Program include improvements emanating from the Standards Improvement Initiative, including the new numbering system and minor language changes for consistency. Please visit The Joint Commission for more information.

Additional Information:

2009 National Patient Safety Goals: Laboratory Services Program. The Joint Commission (TJC). 2008.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/09_lab_npsgs.htm

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October 2008 Clinical Laboratory News: Guidelines Have an Impact but Face Tough Challenges

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By Phil Kibak
American Association of Clinical Chemistry (AACC) Clinical Laboratory News

Data from surveys sent to 102 hospitals, public health laboratories and physician office-clinics were used to assess use of the Clinical and Laboratory Standards Institute (CLSI) performance standards. Only 40% of respondents indicated that they were using the most current CLSI guidelines. But interventions such as technical workshops, national teleconferences, and review of educational materials can lead to changes in this outcome.

Additional Information:

Guidelines Have an Impact but Face Tough Challenges. By Phil Kibak. American Association for Clinical Chemistry (AACC) - Clinical Laboratory News. Volume 34, Number 10. October 2008.
http://www.aacc.org/publications/cln/2008/october/Pages/am08_highlights2.aspx

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Patient Safety Focus: Pre-analytic Labeling Errors

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By Erin Grimm, MD
American Association of Clinical Chemistry (AACC) Clinical Laboratory News

Mistransfusion of blood remains a serious patient safety issue, with the vast majority of mistransfusions resulting from avoidable errors at various points in the transfusion chain. These errors often result in death or major morbidity. But when using rigorous error detection methods these problems may be prevented. Such methods can include 24-hour phlebotomy teams and using bar-coded technology for patient and specimen identification.

Additional Information:

Patient Safety Focus: Pre-analytic Labeling Errors. By Erin Grimm, MD. American Association of Clinical Chemistry (AACC) Clinical Laboratory News. Volume 34, Number 10. October 2008.
http://www.aacc.org/publications/cln/2008/october/pages/1008_safety3.aspx

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HeartNet

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System

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FDA Press Release

Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. For more information, please read the Press Release available under Additional Information below.

You may read a recent MedSun report with this device in the clinical environment online available under Additional Information below. This report is also featured in this month's Highlighted Reports.

Additional Information:

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System. FDA Press Release. October 24, 2008.
http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112525.htm

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HomeNet

Medical Devices: Promoting a Safe Migration into the Home

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By Mary Weick-Brady & Robert Lazerow
PubMed

Medical device use in the home environment has grown in volume and complexity. Because of this, the Food and Drug Administration (FDA) needs to ensure that these products are safe and effective for use in this environment. The FDA must develop a partnership with home healthcare providers in areas of patient education, monitoring device adverse events that occur in the home environment, and communicating problems to the manufacturer.

Additional Information:

Medical Devices: Promoting a Safe Migration into the Home. By Mary Weick-Brady MD & Lazerow RN. PubMed. May 2006.
http://www.ncbi.nlm.nih.gov/pubmed/16699341

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FDA Tools to Assist You and Your Patients with Common Medical Devices Used in the Home

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FDA

Please see the following brochures created by FDA. These brochures offer suggestions for medical device use and maintenance in the home setting.

Additional Information:

FDA Website. Home Healthcare Medical Devices: Blood Glucose Meters - Getting the Most Out of Your Meter. February 29, 2008.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070212.htm
http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070215.pdf

FDA Website. Home Healthcare Medical Devices: A Checklist. August 28, 2003.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070217.htm
http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070218.pdf

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Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way

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FDA Medical Device Safety Website

If you are seeing or have seen issues with your medical device since the recent switch to Daylight Savings Time, please read the following article, which offers recommendations for patients as to how to address potential issues.

Additional Information:

Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way. FDA Medical Device Safety Website. March 1, 2007.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064705.htm

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KidNet

Centers for Disease Control (CDC) Recommendations for Intramuscular Injection and Needle Size

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CDC Pinkbook

The U.S. Centers for Disease Control and Prevention has recommended needle sizes and lengths for intramuscular vaccinations in the thigh and shoulder based on child age. Appendix D in the additional information links contains information specific to the pediatric patient population. Please visit the CDC or the references below for more information.

Additional Information:

CDC Vaccine Administration

http://www.cdc.gov/vaccines/Pubs/pinkbook/downloads/appendices/D/vacc_admin.pdf

CDC - The Pink Book: Appendices. Appendix D. March 28, 2008.
http://www.cdc.gov/vaccines/pubs/pinkbook/pink-appendx.htm#appd

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FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report

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FDA Press Release

We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA's draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct. 31.
The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies.

Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.

Regarding Canada, the FDA notes that Health Canada’s assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects. Out of an abundance of caution, the Government of Canada is taking steps to restrict the use of BPA.

Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.


Statement of the Acting Surgeon General, Rear Admiral Steven K. Galson, M.D., M.P.H.

"The most important thing parents can do for their babies is ensure that they receive adequate nutrition. While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option."

Additional Information:

FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report. FDA Press Release. October 28, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116973.htm

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Arthroscopic Pumps/Tubing

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Over the past 2 years, MedSun has received 14 adverse event reports involving arthroscopic pumps/tubing that occurred in the operating room of the hospitals submitting these reports. These reports are associated with five manufacturers: Arthrex Arthroscopy Instruments, Inc. (9), Stryker Endoscopy (2), Smith & Nephew (1), ConMed Linvatec (1) and DePuy Mitek (1). The reports were submitted by 10 hospitals between October 10th, 2006 and October 10th, 2008. The device problems are:

• Pressure Problems/Pressure Alarm Malfunction (7)
• Over Infusion of Fluid (6)
• Failure to Maintain Power (1)


There are no MedSun reports for this device involving a patient death during this time period. There are 7 reports that mention a device malfunction and 1 report that mentions a device failure. There are 9 reports that mention a patient injury, 7 injuries were reported as minor and 2 injuries required prolonged hospitalization. The patient injuries listed below were reported in 9 of the 14 reports.

• Swelling (5)
• Edema (2)
• Compartmental Syndrome (1)
• Fluid Extravasation (1)

There were no MedSun reports for this device involving a patient under the age of 21 during this time period. From the reports that listed patient age (12 reports, 13 patients), the average age was 57 years old with a standard deviation of 14. Of the reports that listed patient gender, 4 reports involved female patients and 10 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. FDA continues to investigate these problems. If you have experienced these types of problems, please report them to FDA.




MedSun Arthroscopic Pump/Tubing Adverse Event Reports received between October 10th, 2006 and October 10th, 2008
Device Device Identifiers Event Description
Arthrex Arthroscopy Instruments, Inc./Continuous Wave II Model #AR-6400 Patient underwent right ankle arthroscopy and calcaneal nonunion excision. Immediately following the procedure, it was found that the patient had right lower extremity compartments with no pulse of dorsalis pedis artery. Arterial doppler confirmed. Immediate fasciotomy of right lower extremity released four compartments of the leg and pulses immediately returned. Patient transferred to main hospital and admitted. Two days later, patient underwent irrigation and debridement and closure of right lower extremity wound. The patient was discharged in good condition.
Stryker Endoscopy Device Identifiers Unknown The nurse reported during the surgeon's first case of the day, a shoulder arthroscopy, it was noted the pump was using an excessive amount of arthroscopy fluid (34 bags total). The pump was recalibrated partway through the case and seemed to work better. For the surgeon's second case of the day, a different pump (but same make/model) was used and the same problems began to occur. The doctor made the decision to continue operation with gravity fluid rather than continue using the pumps due to safety concerns. The first patient had a moderate amount of fluid extravasation to right shoulder and breast, yet not unusual for this type of surgery. It appeared there was no significant or unexpected injury to the patients. However, it does appear the pumps may have issues with maintaining their calibrations. Of note, a previous report, with the same issue/equipment was filed, which required extended hospital stay.
Arthrex Arthroscopy Instruments, Inc./Continuous Wave III Model #AR-6475 During a knee arthroscopy, a malfunction of the equipment resulted in the infusion of the incorrect amount of fluid into the knee and surrounding tissue.
Stryker Endoscopy Device Identifiers Unknown The patient was undergoing rotator cuff repair where the pump was being used to insufflate the shoulder joint. After the procedure, as drape was removed, it was noted that the patient had severe swelling to neck, breast and shoulder. The pump's purpose is to flush extra fluid into joint to aide during the surgical procedure. There is a drain component to the pump which did not work entirely as intended. Some fluid was removed, but clearly a large amount was retained. The surgeon and anesthesiologist were both concerned by the amount of fluid and possible constriction of the airway, so the patient was admitted for observation in the ICU. This was originally an outpatient procedure. Typically about 16-18 liters of NS is pumped into a patient. However, OR staff did not know how much fluid was collected in the drain. They did say that the fluid leaves the field by suction yankauer as well as through the arthroscopy sites so it is difficult to know exactly how much fluid was retained.
Smith and Nephew, Inc./Dyonics 25 Fluid Management System Catalog #7211010 The pump powered off in the middle of a surgical procedure. After trouble shooting, the pump powered up and continued to work properly for the remainder of the procedure. No harm to patient.
Arthrex Arthroscopy Instruments, Inc./Continuous Wave II Model #AR-6400 During a knee arthroscopy, a malfunction of the equipment and product resulted in the infusion of the incorrect amount of fluid into the knee and surrounding tissue. Upon disconnection of the tubing, fluid projected from the tubing as if under high pressure. No pressure alerts were noted from the pump console while in use.
TD>
Arthrex Arthroscopy Instruments, Inc. Lot #002216Arthrex tubing malfunctioned causing excessive amount of fluid into patient's left leg near the incision site. Swelling of the extremity was noted by the staff. The tubing was replaced and the procedure was competed without incident.
Arthrex Arthroscopy Instruments, Inc. Device Identifiers Unknown Arthroscopic incision and drainage of right knee. Orange thigh stabilizer was used and tourniquet pressure set at 300. Arthrex pressure irrigator set at 80 pressure and 100 flow settings per MD. A total of (5) 3L bags of Lactated Ringer’s solution, (1) 3L and (1) 1L bags of bacitracin irrigation were prepared. There was a large quantity of fluid on floor during the surgery. When the case was over and the drapes were removed, edema was noted to right upper thigh, scrotum, penis and lower abdomen. The patient was then sent to the PACU alert and oriented. The Arthrex rep was then paged by the surgeon. The tourniquet and irrigator were checked by the Biomed with all disposables saved.
Arthrex Arthroscopy Instruments, Inc./Continuous Wave II Model #AR 6400, Lot #004435 Due to constant flow, the tubing was replaced with new tubing and there continued to be inadequate pressure and flow for joint distention. Right knee swelling resulted.
ConMed Linvatec Model #87000 The patient underwent a right knee arthroscopy, lateral menisectomy and limited synovectomy for plica procedure. After the procedure, the nurse noted right thigh swelling. During the surgery, the arthroscopic pump (ConMed) kept alarming unless the start button was pushed continuously by someone. The button was pushed for approximately 40-50 seconds at the beginning of surgery. Since it was not efficient, the pump tubing was changed. Three nurses and two OR techs attempted to troubleshoot the problem and the tubing was still not working. The surgeon decided to use gravity tubing to complete the surgery instead of the arthroscopic pump. The surgeon also stated that he had problems using this kind of pump in the past, however, there have been no other reports of problems at this facility.
DePuy Mitek/FMS Duo Device Identifiers Unknown During arthroscopic knee surgery, the irrigation pressure had been set to 50. During the case, it was noticed that the pump display was reading 100. The irrigation pump did not alarm.The irrigation pump was removed from service following the incident and the tubing from the case was saved. The manufacturer states that the pump will alarm between 10 and 140. These are hard limits and cannot be changed. However, the pump display does not note the units of measure. The display is in ft H2O, but without the decimal point. For example, if the pump displays "50", it has been set at 5.0 ft H2O. The accuracy of the pump display was confirmed using a digital manometer and a 60cc syringe to pressurize the tubing. Pressure was then measured on the digital manometer in cm H2O and then converted to ft H2O. Several measurements were taken to verify the accuracy of the display. It was noted that the pump did alarm for high pressure above 140 (14.0 ft H2O). If the alarm condition is met, the pump motor shuts off and stops fluid delivery, and a red LED lights up to indicate high pressure. There is no audible alarm. In this incident, the tubing leading out of the pressure chamber and leading to the pressure transducer input was filled with water, even passed the water filter. According to the manufacturer, the pressure chamber should only be filled about 1/3 of the way full with fluid. The pressure transducer needs to measure air pressure and excess fluid in the transducer tubing can cause erroneous readings and damage to the transducer.The pump was run using a new tubing set and it operated normally. It was noted that the pump would continue to fill the pressure chamber with water if the clamp below the pressure chamber was left open, or if the connection to the pressure transducer was not secure. The pump will continue to fill the pressure chamber with fluid until the desired pressure is reached.
Arthrex Arthroscopy Instruments, Inc./Continuous Wave III Model #AR-6475 During a right knee arthroscopy, the Arthrex 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 the suction tubing from the canister off, and tried to restart the pump. The pump spun very fast and again stated "Pressure Fault". The nurse then reconnected the suction as 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 was spinning really fast, so the pump was stopped again. At this point, the surgeon stated that the patient's thigh was very hard and he was having difficulty bending the knee. The scope was removed from the knee and the tourniquet was released after only 24 min of being inflated. 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 one minute the same "Pressure Fault" error occurred, however, this time the scope was not in the knee. The tubing was changed on the new pump, 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 happened 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. The pressure calibration problem will not be resolved if the tubing is disconnected and reconnected or if the same tubing is used on a different machine.
Arthrex Arthroscopy Instruments, Inc./Continuous Wave III Model #AR-6475 The arthroscopic pump was set at 45 mmHg per doctor's request. The pump appeared to be functioning correctly. However, at end of case, MD noticed patient's left leg was tight and had a slight edema. RN called Technical Services to look at the pump and noticed the bladder on the tubing pressure sensing component was flattened. RN and the technician switched pumps and tubing altogether. The patient was then sent to the recovery room after surgery for monitoring of left leg. There have been three reports of problems with this device reported to Clinical Engineering. Post event, the device functioned properly and all are most likely related to the tubing used with this device. After an internal analysis, the problem can be replicated in the following way: (Note that this is not the ONLY way). When the tubing set comes from the factory, there is a clamp at the sterile patient end. There is also a cap over the pressure sensing portion, which depresses the piston plunger on the pressure sensing component, opening the lumen of the balloon to the environment. The bags are then spiked and hung. After the bags are hung, the hydrostatic pressure from hanging fluid causes the balloon to collapse easily since the lumen is open to the environment. The cap on the pressure sensor is then removed, and the pressure sensor is plugged into the pump. Because the balloon has low air volume in it, it can easily collapse if it has not already. A pressure sensor with a collapsed balloon is useless. Now, if the company's instructions are followed verbatim by plugging the pressure sensor in FIRST, this problem will likely be avoided. However, there is no force function to require the user to follow the proper steps.
Arthrex Arthroscopy Instruments, Inc./Continuous Wave III Model #AR-6475 At case start after hooking up pump and hooking up camera, light source, shaver and suction, liquid filled the shoulder. The pump was turned off, taken out of service and sent to the Biomedical Department. The tubing was then changed out. The pump was cycling at a high rate of speed. Biomed completely checked out the pump. The operation was normal; pressure sensor operating normally. A possible problem with the disposable tubing was noted. There have been three reports of problems with this device reported to Clinical Engineering. Post event, the device functioned properly and all are most likely related to the tubing used with this device. After an internal analysis, the problem can be replicated in the following way: (Note that this is not the ONLY way). When the tubing set comes from the factory, there is a clamp at the sterile patient end. There is also a cap over the pressure sensing portion, which depresses the piston plunger on the pressure sensing component, opening the lumen of the balloon to the environment. The bags are then spiked and hung. After the bags are hung, the hydrostatic pressure from hanging fluid causes the balloon to collapse easily since the lumen is open to the environment. The cap on the pressure sensor is then removed, and the pressure sensor is plugged into the pump. Because the balloon has low air volume in it, it can easily collapse if it has not already. A pressure sensor with a collapsed balloon is useless. Now, if the company's instructions are followed verbatim by plugging the pressure sensor in FIRST, this problem will likely be avoided. However, there is no force function to require the user to follow the proper steps.

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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 30. 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: Carts, Medication
Manufacturer: Armstrong Medical LTD
Problem:
A nurse discovered our crash carts really do not lock. The newer version we have only has one metal tab thus allowing yellow plastic lock to slide through slot allowing drawers to be opened. I have pictures to show older models and new models.

======================
Manufacturer response for Crash Carts, Pediatric ALS Color-Coded Cart and Adult Carts
======================

They do not seem to understand the problem and I have sent pictures but rep cannot come until next week. We discovered this last week. We are concerned this may be a widespread problem with this cart and people may not be aware that cart really is not locked when it seems to be locked.

Please see crash cart lock images.
New adult crash cart showing how lock can slide through slot resulting in cart not being locked. New pediatric crash cart showing how lock can slide through slot resulting in cart not being locked. New pediatric crash cart showing how lock can slide through slot resulting in cart not being locked. Old model crash cart showing superior locking design.  Lock unable to slide throguh the slot.


CARDIOVASCULAR

Device: Lead, Lvad
Model# Heartmate II
Manufacturer: Thoratec Corporation
Problem:
In the postoperative period, the patient was noted to have intermittent pump stoppage consistent with a cracked percutaneous lead. The percutaneous lead underwent a radiography and demonstrated a potential crack along its distal portion. The patient was taken emergently to the operating room for replacement of the HeartMate II left ventricular assist device.

Please see recall on this device online available at http://www.fda.gov/oc/po/firmrecalls/thoratec10_08.html

Device: Monitor, Physiological
Model# Dash 4000
Manufacturer: GE Medical Systems Information Technologies
Problem:
Monitors would beep then screen would go blank, a few seconds later screen would come back but data would be changed and clock time is off. This happened with several monitors so it affected several babies.


GASTROENTEROLOGY &UROLOGY

Device: Control Valve, Ro
Model# 2850
Manufacturer: Pentair - Home of Fleck
Problem:
In our Dialysis unit we have 4 Fleck heads mounted on tanks for a multimedia filter, a water softener, and 2 carbon tanks that treat our incoming water before it enters the RO system. During a three week period, three of the pistons inside of the Fleck heads broke off of the piston shaft and became stuck; all three were pushed in fully when the break occured. This interrupted dialysis when the piston for the carbon tank broke, and patients were diverted to another facility until replacement parts were obtained and installed.

Device: Reprocessing Machine, Endoscopy
Manufacturer: Olympus America Inc.
Problem:
One of the automatic endoscopic reprocessing (AER) machines was found to have a broken connector tube, which is used to flush the high-level disinfectant through the inside channel of the scope during reprocessing. Endoscopic reprocessing includes an initial manual cleaning with an enzymatic detergent, brushing inside channels and exterior surfaces and thorough rinsing. The automated process includes leak testing, submersion and flushing all lumens with high-level disinfectant for several minutes (per manufacturer's recommendation), rinsing all surfaces, with a final alcohol flushing of lumens and forced air sent through the channels to facilitate drying. This particular connector tube was found coiled in one of the AER reprocessing chambers after the last day's run cycle. When it was straightened the tube was found severed in half at the base. It is unknown if the break during the straightening of the tube or if it had been broken during previous run cycles, thus potentially preventing adequate high-level disinfection of the (inner lumens) of scopes reprecessed in that particular machine.

======================
Manufacturer response for Disinfector, Olympus DSD
======================

Olympus contacted to determine if the machine would automatically abort a run if there was a break in the connector tube. Olympus said it would not abort, it would abort only if the tubing is completely occluded or if the leak test fails.

Device: Tubing, Insufflation
Model# 620-040-690
Manufacturer: Stryker Endoscopy
Problem:
Tip broken off tubing where it connects to laparoscopic trocar.

======================
Manufacturer response for insufflation tubing, PneumoSure insufflation tubing
======================

The rep verbally reported that the company has been aware of the problem with the glue in this tubing for several months. They are apparently working on a solution, but no adequate replacement will become available for several more weeks and they continue to provide tubing with known breakage issues.


GENERAL HOSPITAL

Device: Infant Abduction System
Model# PRO-ROAM-UMB
Manufacturer: Prosec Protection Systems Inc.
Problem:
Nurse discovered bleeding from umbilical cord. This is the third incident in which the cord clamp has failed.

In reviewing these incidents, we have hypothesized that the transponder for the infant security system may have contributed to the failure of the clamp. The transponder is placed in the ring at one end of the clamp. The transponder is held very tightly by clamps from this manufacturer. (Nursing staff does not recall having similar problems with our previous clamp manufacturer.)

After reporting these incidents to the clamp manufacturer, we have been informed that their device is not compatible with the transponder system. Also, according to the maker's of the transponder system, the only clamp that is designed to be used with the system is their own proprietary clamp.

Device: Prep Solution With Applicator, Chloraprep
Manufacturer: Cardinal Health
Problem:
RN was prepping patient with Chloraprep sponge for IV insertion. Patient's skin was scratched, causing some bleeding, from something sharp coming through the sponge.

Device: Pump, Implantable
Manufacturer: Medtronic Inc. (Neurological)
Problem:
To determine whether the pump was working properly, biomed performed testing using dye. Testing revealed that the dye never reached the catheter. We have had this issue with other pumps, as well as catheter patency issues. The patient will be started on oral baclofen and then the family will be given the choice between explant or replacement.

Device: Pump, Infusion
Model# Prizm
Manufacturer: Smiths Medical
Problem:
The patient was connected to a TPN infusion during the evening, and the following morning no reduction in solution volume within the bag was noted. The pump produced no alarm and the patient indicated that the pump sounded like it was working during the intended infusion.

Device: Pump, Intrathecal
Model# 8637-40
Manufacturer: Medtronic Neurological
Problem:
Patient with intrathecal pump. Outside medication provider unable to refill pump. Patient to neurosurgery clinic. Unable to refill pump. Patient to OR for replacement of pump and new medication. Pump was found to be plugged. Medication from outside company noted to be cloudy.



Device: Syringe, Pre-filled, Heparin
Model# 10units/ml 3ml in 12ml syringe
Manufacturer: Amsino Medical USA
Problem:
RN went to heparinize a patient's central line after IV push medication. RN obtained a pre-packaged heparin flush syringe, attached to the central line and attempted to push in heparin and met resistance in the line. RN d/cd the syringe from the line to discover that the syringe was empty - syringe did not have heparin, but only air.



OBSTETRICS/GYNECOLOGY

Device: Umbilical Cord Clamp
Manufacturer: Owens & Minor, Inc.
Problem:
Nurse discovered bleeding from umbilical cord. This is the third incident in which the cord clamp has failed.

In reviewing these incidents, we have hypothesized that the transponder for the infant security system may have contributed to the failure of the clamp. The transponder is placed in the ring at one end of the clamp. The transponder is held very tightly by clamps from this manufacturer. (Nursing staff does not recall having similar problems with our previous clamp manufacturer.)

After reporting these incidents to the clamp manufacturer, we have been informed that their device is not compatible with the transponder system. Also, according to the maker's of the transponder system, the only clamp that is designed to be used with the system is their own proprietary clamp.


RADIOLOGY

Device: X-ray Machine, Portable, Digital

Model# 5151481-3
Manufacturer: GE Medical Systems, LLC
Problem:
The X-ray machine malfunctioned when tech was attempting to take an X-ray on a patient. The machine did not beep when the X-ray was being taken. While techs were assessing the problem, the patient's mother stated that there was smoke. It was coming from the digital detector that was near the patient. When the technician picked up the detector by the handle, she touched the cable which was very hot. Device was removed from service.

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Manufacturer response for X-ray machine, portable, digital
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GE replaced both the cable that got hot as well as the power supply. GE contends that a circuit breaker within the power supply should have prevented this type of event. Power Supply was sent to GE headquarters for further evaluation.

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Updated December 1, 2008

Return to MedSun: Medical Product Safety Network

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