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U.S. Department of Health and Human Services

MedSun: Newsletter #36, May 2009

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Newsletter #36, May 2009

Articles

Update Regarding the Availability of Rapid Influenza Tests and Viral Transport Media

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May 7, 2009

It has come to our attention that many customers are experiencing problems with the availability of rapid influenza tests and viral transport media. Some manufacturers are experiencing backorders; but others say they still have a supply.

We have been informed that manufacturers are ramping up production and are receiving new lots of product on a daily and/or weekly basis. To meet the needs of all customers, many manufacturers have implemented manual allocation of products. Please contact the manufacturer directly for product availability.

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Class 1 Recall: Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide

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Medtronic and FDA notified healthcare professionals about a Class I recall of the Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide due to the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery.

Additional Information:

Class 1 Recall: Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide. FDA Recall Notice. February 12, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm126620.htm

Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide. FDA MedWatch Alert. March 27, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127791.htm

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Class 1 Recall: Tri-State Hospital Supply Corporation - Centurion Trays and Kits

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Tri-State Hospital Supply Corporation initiated a recall on January 14, 2009 for a variety of Centurion Trays and Kits due to weak package sealing which may affect the sterility of the devices. The affected products were manufactured from November 17, 2008 through November 21, 2008 and distributed from November 24, 2008 through January 7, 2009. The company sent their distributors and customers a recall notice on January 14, 2009.

They were instructed to:
•remove the products from their inventory
•inform the company of the number of products in stock
•hold the products until the company arranges for their return

Additional Information:

Class 1 Recall: Tri-State Hospital Supply Corporation - Centurion Trays and Kits. FDA Recall Notice. January 14, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm129701.htm

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Class 1 Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons

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Teleflex Medical and FDA notified healthcare professionals of the Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart. This recall is being conducted because a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

Additional Information:

Class 1 Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons. FDA Recall Notice. February 2, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm134877.htm

Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters. FDA MedWatch Alert. April 15, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm136535.htm

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Class 1 Recall: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator

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ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. See the Zoll letter for details.

Additional Information:

Class 1 Recall: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator. FDA Recall Notice. February 12, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm132683.htm

ZOLL AED Plus Defibrillator. Customer Letter. March 31, 2009.

http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM134070.pdf

ZOLL AED Plus Defibrillator. FDA MedWatch Alert. April 9, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm134068.htm

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Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use

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The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user. The FDA is working with the Centers for Disease Control and Prevention, professional societies and healthcare organizations to reinforce patient and healthcare provider education about proper and safe use of insulin pens.

Additional Information:

Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use. FDA MedWatch Alert. March 19, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127783.htm

Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens. March 19, 2009.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm133352.ht

FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared. FDA News Release March 19, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149546.htm

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Adverse Events in Hospitals: Overview of Key Issues

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A Report from the Department of Health and Human Services Office of Inspector General, December 2008

The Tax Relief and Health Care Act of 2006 (the Act) mandates that the Office of Inspector General (OIG) report to Congress regarding the incidence of “never events” among Medicare beneficiaries, payment by Medicare or beneficiaries for services furnished in connection with such events, and the processes that the Centers for Medicare & Medicaid Services (CMS) uses to identify events and deny payment. Never events are a specific list of serious events, such as surgery on the wrong patient, that the National Quality Forum deemed “should never occur in a health care setting.” Expanding beyond this specific list, this and subsequent OIG reports use the broader term “adverse event” to provide for a more comprehensive examination of key issues. This report is one in a series to fulfill the requirements in the Act and inform decision-makers.

To facilitate OIG efforts to comply with the mandate, the OIG staff first sought to identify key issues regarding adverse events in hospitals to provide direction and context for their work. This overview report combines evidence, analysis, and opinion from a wide range of sources. These sources, referred to collectively as “stakeholders,” represent diverse entities involved in addressing adverse events in hospitals, including government agencies and other policymakers, professional associations, oversight organizations, patient safety groups, providers, and researchers.

KEY ISSUES
OIG identified the following seven issues as most critical to understanding the landscape of adverse events in hospitals:

Issue 1: Estimates of the incidence of adverse events in hospitals vary widely and measurement is difficult. Research estimates of the frequency of adverse events in hospitals vary from 3 percent to 20 percent of hospital admissions, in part because there is no optimal method for measuring incidence. Research also indicates that elderly patients are particularly vulnerable.

Issue 2: Nonpayment policies for adverse events are gaining in prominence and are viewed as a powerful incentive to reduce incidence but raise potential drawbacks. CMS’s new policy will deny hospitals higher payment for admissions complicated by selected adverse events, and private health care payers are adopting similar policies. Stakeholders generally believe that nonpayment provides an incentive to prevent costly adverse events. Potential drawbacks of nonpayment raised by stakeholders include limited access to care, increased hospital costs, and reduced hospital revenue.

Issue 3: Hospitals rely on staff and managers to report adverse events internally, but barriers can inhibit reporting. Reporting events and suspected causes can help hospitals improve practices to prevent adverse events and ensure accountability for poor care. Hospitals also use reported information to inform affected patients and families, which is thought to boost public trust, and to improve clinical decision-making and compliance in treatment. However, hospital staff may not report events because they do not believe that reports will lead to improvement, do not have time, or fear punitive action.

Issue 4: Hospitals report adverse events to various oversight entities, although stakeholders suspect substantial underreporting. Although there is no comprehensive national reporting system for adverse events, a number of Federal, State, and nongovernmental entities receive adverse event reports from hospitals. Hospitals are believed to underreport adverse events, although it is difficult to know to what extent. However, stakeholders indicated that reporting every adverse event is not necessary to achieve the aim of improving practices to prevent adverse events.

Issue 5: Public disclosure of adverse events can benefit patients but also raises legal concerns for patients and providers. Access to adverse event information provides public scrutiny that may pressure hospitals to improve practices. However, concerns that hospitals, clinicians, and patients can lose legal protections when adverse event information is reported can inhibit full disclosure of adverse events.

Issue 6: Information to help prevent adverse events is widely available, but some hospitals and clinicians may be slow to adopt or routinely apply recommended practices. Hospitals and clinicians are sometimes slow to adopt recommended practices, such as evidence-based clinical practice guidelines, which outline systematically developed procedures to improve care. Literature indicates that hospital staff and clinicians may believe that the guidelines are not relevant to their setting or that they value individual practitioner judgment more than regimented standards of care.

Issue 7: Interviews and literature reveal strategies that may accelerate progress in reducing the incidence of adverse events in hospitals including:
-Assessing the desirability and feasibility of a national body to lead patient safety efforts, which would help to coordinate, but not replace, current efforts by government agencies and private entities;
-Focusing on hospital use of recommended practices and evidence-based guidelines to reduce the incidence of adverse events, including measuring hospital use;
-Establishing methods for measuring the incidence of adverse events, including tools for practical and accurate data collection;
-Expanding the use of electronic health records within and between hospitals, thus improving communication and continuity of care to potentially reduce the incidence of adverse events;
-Monitoring the impact of policies to deny hospitals higher payment for admissions complicated by selected adverse events; and
-Improving the utility of adverse event reporting, including evaluating the comparability of data reported across entities and streamlining reporting mechanisms to reduce burden on hospitals.

Additional Information:

U.S. Department of Health and Human Services. Office of the Inspector General. Adverse Health Care Events. December 2008.
http://www.oig.hhs.gov/oei/a.asp#adverse_care

U.S. Department of Health and Human Services. Office of the Inspector General. Adverse Health Care Events. Full Report. December 2008.

http://www.oig.hhs.gov/oei/reports/oei-06-07-00471.pdf

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Data Snapshot: Iatrogenic Burn Injuries

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Pennsylvania Patient Safety Authority

In 2007, the Pennsylvania Patient Safety Authority received 224 reports of burns, singes, or sparks occurring in the healthcare facility. These burns were reports of actual or proximal harm to the patient. More than half the submitted burns were reported to have been caused by instruments or devices used in procedures, including cautery units, lights sources, and cords for these devices. Based on additional figures from the Pennsylvania Health Care Cost Containment council, an estimated 11.9 burns occur per 100,000 admissions in Pennsylvania.

Additional Information:

Data Snapshot: Iatrogenic Burn Injuries. Pennsylvania Patient Safety Authority – PA Patient Safety Advisory. March 2009.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/36.aspx

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Safety in the MR Environment

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Pennsylvania Patient Safety Authority

Electromagnetic and ferromagnetic materials in close proximity to a magnetic resonance imaging (MRI) scanner can be a hazardous safety risk to any individual near the scanner. To avoid injury from interference and attraction effects, individuals are screened before entering the MRI room. This article provides educational tools and links to other articles to prevent these errors.

Additional Information:

Safety in the MR Environment. Pennsylvania Patient Safety Authority - PA Patient Safety Advisory. 2009.
http://www.patientsafetyauthority.org/EducationalTools/PatientSafetyTools/mr/Pages/home.aspx

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Faucet and sink design contribute to splashing, ICU outbreak with resistant organism and 12 deaths

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SafetyShare Newsletter, Premier, Inc

A multi-drug resistant organism (MDRO) causing an ICU outbreak and at least 12 deaths was associated with poor placement of handwashing sinks and environmental contamination. A recent study from the University of Toronto illustrates the importance of room design, particularly the location and design of sinks, and how sink drains were identified as the reservoir of pathogens in a major outbreak. The article lists important steps facilities can take to help prevent these outbreaks.

Additional Information:

Faucet and sink design contribute to splashing, ICU outbreak with resistant organism and 12 deaths. SafetyShare Newsletter, Premier, Inc. April 22, 2009.
http://www.premierinc.com/quality-safety/tools-services/safety/safety-share/04-09-full-txt.jsp#story-01

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LabNet

Update Regarding the Availability of Rapid Influenza Tests and Viral Transport Media

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See an important update regarding the availability of Rapid Influenza Tests and Viral Transport Media on this month's homepage.

Additional Information:

Update Regarding the Availability of Rapid Influenza Tests and Viral Transport Media
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=36#1

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MRSA Screening Used to Decrease SSIs

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American College of Surgeons Surgery News

A recent study showed that universal preoperative surveillance for methicillin-resistant Staphylococcus aureus infection coupled with eradication before all elective procedures was not significantly better than screening of high-risk patients and eradication for decreasing the rate of surgical site infections (SSIs) at a large hospital.

Additional Information:

MRSA Screening Used to Decrease SSIs. American College of Surgeons Surgery News. Volume 5, Number 2. February 2009.

http://www.facs.org/surgerynews/0209.pdf

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HomeNet

Bringing Medical Devices Home

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Medical Device and Diagnostic Industry

Because of changes in healthcare, medical devices (both critical and noncritical) are used more often in the home and are used in different ways from in the hospital. This article discusses the challenges and experiences of those using medical products in the home.

Additional Information:

Bringing Medical Devices Home. Medical Device and Diagnostic Industry. February 2008.
http://www.devicelink.com/mddi/archive/08/02/004.html

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KidNet

Ceftriaxone (marketed as Rocephin and generics)

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FDA notified healthcare professionals of an update to a previous alert on the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. Based on the results of new studies FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients over 28 days of age, using the precautionary recommendations noted because the risk of precipitation is low in this population.

Additional Information:

Ceftriaxone (marketed as Rocephin and generics). FDA MedWatch Alert. April 14, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm136533.htm

Information for Healthcare Professionals: Ceftriaxone (marketed as Rocephin and generics). April 21, 2009.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084263.ht

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FDA Approves Cardiac Adhesion Barrier for Pediatric Use

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The FDA announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery. Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.

Additional Information:

FDA Approves Cardiac Adhesion Barrier for Pediatric Use. FDA Press Release. March 6, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149538.htm

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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 February 1 through February 28. 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.


ORTHOPEDIC

Device 1: Needle, Suture
Manufacturer: Arthrex Arthroscopy Instruments, Inc.
Brand: Scorpion -Surefire Needle
Model #: AR-13991N
Lot #: 170421

Device 2: Needle, Suture
Manufacturer: Arthrex Arthroscopy Instruments, Inc.
Brand: Scorpion -Surefire Needle
Model #: AR-13991N
Lot #: 170421

Problem:
During an arthroscopic rotator cuff repair of the left shoulder, the procedure tips of the scorpion needle (2 pieces) broke off in the shoulder while going through tissue. The tips were both approximately 3.0 mm each. The surgeon was unable to locate them. A post-op x-ray showed both pieces in the shoulder.


ANESTHESIOLOGY

Device: Anesthesia Delivery Unit
Manufacturer: GE Healthcare
Brand: S/5 Avance Carestation

Problem:
During a cardiac procedure on an infant with an interrupted aortic arch defect, the inspired CO2 reading on the anesthesia machine started rising to the mid 30mmHg CO2. The patient was under pressure support ventilation on the anesthesia machine's ventilator. The patient's pCO2 was starting to give readings above 100mmHg and physician was concerned about respiratory acidosis occurring. The Physician then exchanged the ventilator to a stand alone vent and was able to get the inspired CO2 to drop in pressure support ventilation on the exchanged ventilator. Physician noted to Biomedical that elevated inspired CO2 readings were occurring frequently during pressure support ventilation on all the anesthesia machines while ventilating infant patients and neonates.


GASTROENTEROLOGY/UROLOGY

Device: Dual Port Feeding Tube With Flow-through Stylet
Manufacturer: Covidien Kendall
Brand: Entriflex
Cat #: 8884-721088

Problem:
ICU RN attempted to place a NG tube, but was not able to pass it past the right or left nares. The charge RN then attempted and easily passed the tube on the right side. Air was auscultated over the stomach and an x-ray was obtained. The x-ray showed a pneumothorax in the right lung. The MD was notified, and ultimately the patient had a chest tube placed to relieve the pneumothorax. This is a new device for our facility. Staff noted that the new device has a weighted tip, which they believe may have contributed to the pneumothorax because they believe the RN had less sense of resistance.

Device: Catheter, Foley
Manufacturer: C.R. Bard
Brand: Bardex
Model #: 165816
Lot #: NGS10155

Problem:
The balloon failed to deflate completely. The nurse followed standard protocol, which consisted of attaching a syringe and allowing the balloon to deflate. When catheter was removed, the patient complained of pain in the urethra. The nurse observed resistance to removal. Upon removal, nurse observed cuffing of the balloon.

The site has not heard back from sales representative. A message was left two business days ago.
In previous incident, manufacturer had stated that balloon on all silicone catheters tend to have incomplete deflation resulting in cuffing; reportedly silicone does not have the same degree of "memory" that latex balloons have.

Patient had pain during and after removal of catheter.
FDA comment: FDA has received other reports on this issue


CARDIOVASCULAR

Device: Pump, Centrifugal Blood, ECMO
Manufacturer: Medtronic Perfusion Systems
Brand: Bio-pump
Model #: BP50
Lot #: 85185-00

Problem:
An infant underwent open heart surgery and post operatively was immediately placed on ECMO. Three days later, the patient underwent a circuit change. Approximately 48 hours later, the nurse was cleaning blood off a stop cock near the cone (Bio-Pump) with a saline soaked 4x4. When she wiped blood off the cone from the stop cock, she noted the cone to have fine cracks on it. She notified the MD. The cone started to leak blood. The cone was changed. Baby desaturated during the change. Baby recovered on ECMO and remains on ECMO.

Cracked ECMO Pump

Device: Monitor, Physiological, Wireless
Manufacturer: GE Healthcare
Brand: Dash 4000, Wireless
Model #: Dash 4000 Wireless

Problem:
Approximately two months ago we began experiencing 'NO-COMM' issues with GE wireless dash 4000 monitors running on an 802.11b network. The main software = 6.4, main boot software = 6.3, Dash boot software = 6.0, ECG SW = 1A, Spo2 = 1599V4.0.0.1. We have been working on a daily basis with GE and our own IS networking team. As many as 50% of the monitors have experienced communications issues. The symptom of 'no-comm' causes the data transfer between the bedside monitor and the nurse’s central station to lose monitoring capabilities as shown at the central station. At that point only the bedside monitor can alarm and display physiological information. The following is a list of troubleshooting already performed:

1) Sent log files to GE for December and January.
2) Opened a GE I-trac to dedicate GE engineers and technicians to this problem.
3) Replaced the central station in attempts to verify a hardware issue.
4) Set up a central station complete with monitors and simulators in a test environment to troubleshoot hardware and IS networking.
5) Sent several more log files to GE from the Grant 6 respiratory dept who have experienced (and made us aware) of a very large number of ‘no-comm’ (No communications) situations that have affected patient care.
6) Received reports from GE engineering who recommended several hardware and networking settings to be verified.
7) Coordinated several teleconferences between GE, Clinical Engineering and IS networking groups.
8) Set up an alternative switch/hardwired network in a test environment to determine if any hardwired communications or data is being affected. No hardwired devices have experienced any issues.
9) Moved 'no-comm' dash monitors to other areas to see if the problem followed them for network vs. monitor troubleshooting.
10) Fully tested the 'no-comm' monitors in a test environment which confirmed the problems.
11) Sent more log files of 'no-comm' monitors as verified in a test environment to GE for analysis.
12) Have now determined that 'no-comm' problem is spread across all wireless dash areas.
13) Have initiated a PO to secure GE engineers to troubleshoot on site networking and wireless dash configurations.

Device 1: Module, Physiological Monitor
Manufacturer: GE Healthcare
Brand: Pdm, Carescape
Model #: PDM, Carescape

Device 2: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Transport Pro
Model #: Transport Pro

Device 3: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Solar
Model #: SOLAR 8000I

Problem:
Pt was admitted to the MICU when several attempts were made to transfer the patient to the solar monitor using the PDM (Tram module) and the bedside PDM docking station. Each attempt was unsuccessful. Additional PDMs were used without success. Biomed found that the Eport (connector on the rear of the PDM module) on the PDMs were bent and the Eport connector on the PDM docking station was also bent therefore the PDM could not connect. This critical pt. had to be monitored with a defibrillator until Biomed got another PDM that did not have a bent Eport and the PDM docking station had to be replaced. Other equipment was used to monitor the pt hemodynamics during the wait for a new PDM and PDM docking station. The Eport connector on the PDM as well as the PDM docking station's Eport connector is a poor design and GE has been made aware via itrack which occurs every time we encounter this problem and notify GE. This is not the first problem we have had with the PDM and the Eport connectors. GE has been replacing all the PDMs with bent or broken Eport connectors, but something rather than just replacing parts must be done about the design of the PDM. We have also noticed this problem with the PDM and PDM docking station on the transport pro monitors.
======================
Manufacturer response for Module, Physiological Monitor, PDM, Tram, Monitor, Physiological Transport Pro and Solar
======================
GE has replied to emails stating that they have forwarded our concerns to their headquarters. A GE nurse has contacted us to find out about the events involving this patient. However we have had no follow up on how GE plans to fix the design on the PDM's Eport/Eport connectors and docking station.

Device: Wall Mount, Physiolgical Monitor
Manufacturer: Philips Medical Systems
Brand: MSeries
Model #: M Series WMM-0001-01B
Problem:
Newly installed (within the last year) Phillips ECG monitoring mounts are working loose at the joint next to the monitor for horizontal movement.
======================
Manufacturer response for Wall Mount, Physiological Monitor, M Series
======================
They are unaware of this happening elsewhere.

Device 1: Defibrillator, External, Biphasic
Manufacturer: Zoll Medical Corporation
Brand: MSeries

Device 2: Defibrillator, External, Monophasic
Manufacturer: Zoll Medical Corporation
Brand: MSeries
Model #: Type M

Device 3: Magnetic Navigation System
Manufacturer: Stereotaxis, Inc.
Brand: Niobe
Problem:
Patient was being treated for atrial flutter during an ablation procedure in the Stereotaxis room. The Stereotaxis system was not being used and was in the stowed position. The patient went into atrial fib and required cardioversion. A Zoll biphasic defibrillator was moved closer to the patient, which put it within 6 feet of the stowed Stereotaxis magnet. The defibrillator was displaying an ECG and "sync markers”, showing that it was ready to cardiovert. When the charge button was pressed, it displayed an error code and a “sync error” message. The electrodes were then connected to the second defibrillator (Zoll monophasic) and the charge button was pressed. Again an error message was displayed, reading “defib error”. A third Zoll defibrillator from another area was brought in and, this time, was held in a different location, closer to the patient, by a cath lab staff member. This defibrillator charged and fired normally. Patient was cardioverted. The two defibrillators were tested outside of the room and functioned properly. It is believed that the two defibrillators which were originally used may have been located within the "5 gauss line" of the Stereotaxis magnets (about 6 feet). The location of the defibrillator which later charged and fired properly was further from the magnet (next to the patient, at mid-table).
======================
Manufacturer response for Biphasic defibrilator, (Zoll)
======================
They were not aware of any other events of this type.
======================
Manufacturer response for Monophasic defibrillator, (Zoll)
======================
Not aware of this happening


GENERAL HOSPITAL

Device 1: Syringe, 60ml, Luer Lock
Manufacturer: Becton Dickinson

Device 2: Syringe, Catheter Tip, 60ml, Graduated
Manufacturer: Becton Dickinson

Device 3: Catheter, Jejunostomy, Baker
Manufacturer: Bard Access Systems

Device 4: Port, Vascular Access
Manufacturer: Bard Access Systems

Device 5: (Gastroenterology & Urology): Feeding Tube, Gastrostomy
Manufacturer: Kimberly-Clark Corporation

Problem:
A patient was scheduled for a radiology study to evaluate the reason for a non-functioning jejunostomy. Hypaque (an oral contrast material) was mixed with tap water, placed in a Luer lock syringe and injected into the patient’s Port-a-cath by the rad tech. The radiologist was alerted to the misadministration because no contrast was going through the patient’s J-tube during fluoroscopy. The injection was immediately stopped and the radiologist aspirated the contrast from the Port-a-cath tube until blood appeared (3ml). The line was then flushed with saline.
Two techs were involved in the preparation. The patient handed the tech what he thought was the J-tube. The tech saw that it was a Luer connection and placed the contrast in a Luer syringe for administration. The tech interpreted what he thought was the patient’s tube feeding (but it was actually a lipid infusion) and injected the oral contrast.

This is an unusual exam. One tech was fairly new and hadn’t done this procedure before. The other seasoned tech had done this procedure once before. Another contributing factor was the fact that the patient’s port-a-cath line was routed through a telemetry pouch that was built into the patient’s gown. The line was not traced to the patient’s skin.

Both Luer lock syringes and graduated tip syringes are available in the storage room. Luer lock syringes are necessary for aspirations and IVP studies. The graduated tips are generally used for enteral tube access.

Once the assisting tech saw the port that needed to be accessed, a Luer lock syringe was retrieved and used to draw up the contrast material. The connection was easily made and there was no tactile warning that a connection error had occur.

Normally a syringe with a graduated tip is used for J or G tube access. Luer connecting syringes are used to access NICU enteral tubes. Feeding tubes for NICU patients are manufactured so that a Luer syringe is needed to access the port.

The patient had been immunocompromised due to recent chemotherapy and was on broad spectrum antibiotics prior to this event. 2-3 hours after the event, the patient became hypotensive and was transferred to ICU. Blood cultures have been negative. The patient has been transferred out of ICU and is doing well. No other patient information is known.

Device: Hospital Bed
Manufacturer: Graham-Field Health Products, Inc.
Brand: Whisperlite Ii
Model #: WL0208

Problem:
Patient's caregiver called to report that the foot of the bed on the right side collapsed while patient was in the bed. Patient was not injured and did not have to seek any medical attention. The Home Medical technician made a home visit to repair the wheel on the bed which appeared to have contributed to the foot section leaning.

Device: Intrathecal Pump
Manufacturer: Medtronic Neuromodulation
Brand: Synchromed-ii
Model #: 8637-40

Problem:
Pump had motor stall. Telemetry reviewed. Found one stall with a restart then a second stall without a restart. Pt required a new pump to be placed.

Device: Exam Gloves
Manufacturer: Cardinal Health
Brand: Esteem Stretchy Nitrile
Lot #: Thin: 2Y08P002; Norm: 9R08K032
Cat #: 8817N
Other #: (01) 0 0380470 05765 1

Problem:
The company sent thinner, non chemo-tested and non lab-tested blue gloves in a slightly smaller box with the same product code as a box that contains bona fide chemo-tested and lab-tested gloves. This means that our lab, oncology and pharmacy staff will be using gloves that they think will protect them but may not. At this point, there are not any known exposure incidents to staff or patients.
======================
Manufacturer response for Exam Gloves, Esteem Stretchy Nitrile
======================
Manufacturer's rep acknowledged a manufacturing problem. Our distributor heard about it from us.

Device: Set, Enteral Feeding
Manufacturer: Covidien (Kendall)
Brand: Kendall (E-pump Kangaoo Tubing -1000ml Pump Set W/1000ml Flush Bag)
Lot #: 8319304, 8333307, 8347451
Cat #: 773662

Problem:
Late last summer, we first reported to Kendall that the tubing was not priming. They said it was an educational issue and did another in-service. Three months went by without complaint, but the same problem was recently reported. Once again reported to Kendall. Lot numbers include: 8319304, 8333307, 8347451, 8326306, 8312293.

Device: Set, Enteral Feeding
Manufacturer: Covidien Kendall
Brand: Kangaroo Feeding Pump Set With Flush Bag
Lot #: 8234160
Cat #: 773662

Problem:
The feeding line cannot be primed and nursing is having to try many sets before finding one that works. This causes a delay in therapy. The tubing sets are correctly placed on the machine with the rotary valve (aka, anti free flow valve) sitting in a well over the valve shaft, a segment of tubing that wraps around a peristaltic wheel and an identification magnet that sits in another well over a sensor. At the appropriate moment, the pump attempts to turn the rotary valve but it won't turn due to a manufacturing problem so the valve stays in the no flow position. Meanwhile, the valve shaft turns against the nylon teeth of the rotary valve and makes chewing marks on those teeth.

In our discussions with the manufacturer, they told us that a silicone lubricant was not applied to the rotary valve body during assembly. The valves are used by both the 773662 and 774669 (w/ spike instead of flush bag) sets. They sent us some replacement cases free of charge. They worked with the distributor to get affected lots off the distributor's shelves but they didn't issue a formal recall nor inform us exactly which lots were bad.

Device: Iv Tubing
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Smartsite Infusion Set Iv Tubing
Model #: 2420-0007
Other #: 08125224

Problem:
IV tubing found disconnected from the Y-Site, and was in the patient’s bed. The tubing was infusing hyperalimentation at time of the disconnection. The tubing was intact, and the Y-Site was intact. Disconnection with this type of tubing has occurred approximately 2-3 other times. We were unable to delineate the possible cause, but considering the frequency, the tubing is being questioned. All events involved TPN (total parenteral nutrition).

Device: Iv Tubing
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Smartsite Infusion Set
Model #: 2420-0007
Other #: 08125473

Problem:
IV tubing was found to be leaking after it was primed and placed in the infusion pump. The tubing was removed from the pump, and a hole in the tubing was noted. The tubing was never connected to the patient, so there was no patient harm.

Device: Tubing, Iv
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Alaris Pump Module Administration Set
Lot #: H370240105001
Cat #: 2401-0500

Problem:
A new administration set was opened for use. While the tubing was being primed (flush all air out of the tubing with fluid prior to use), it was noted to have debris that looked like pieces of plastic in it. The tubing was never connected to the patient.

Device: Infusion Pump
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Signature Gold
Model #: 7130B

Problem:
Alaris Pump kept alarming "performing self-checks" with instructions to remove the IV cassette. This happened three times, at which time the Alaris pump was exchanged for a new one. Maintenance IV fluids were infusing at the time the Alaris pump was alarming.


GENERAL AND PLASTIC SURGERY

Device 1: Laser, Holmium
Manufacturer: Lumenis, Inc.
Brand: Versapulse Powersuite
Model #: Powersuite-20W

Device 2: Laser Fiber, Reuseable
Manufacturer: Lumenis, Inc.
Brand: Slimline 365 Fiber
Model #: Slimline 365

Problem:
Patient undergoing extraction of an ureteral stone with holmium laser. During the procedure the laser fiber made an audible "pop" noise and flashed. All staff and the patient were wearing eye protection. There was no evidence of laser contact to skin (of patient or staff). The laser unit and fiber were removed from service and inspected by a biomedical engineer. The laser unit was tested with a test fiber and found to be functioning properly. The blast shield was replaced because it was "damaged." (The blast shield acts as a "fuse" and protects the laser's internal components in the event of a fiber failure.) The laser was placed back in service. The engineer did not inspect the fiber, but it was retained in the event the manufacturer requests to inspect it. The laser fiber is a reusable item. We do keep track of how many times they are used/sterilized. They can be used up to ten times, but usually do not achieve that number. They are inspected and trimmed with a tool after each use.

The fibers can be used up to 10 times. We keep track of the times the fiber has been used/sterilized by marking the container the fiber is sterilized in. We have a cutting/trimming tool for the fibers according to size. The reuseable fibers are discarded for the following reasons:

1. The fiber is trimmed to the point that it's too short to reach from the laser to the sterile field.
2. The fiber has been used 10 times.
3. After each trim, the fiber is checked with an inspection scope to check for damaged fibers. If there are damaged fibers that can't be trimmed, the fiber will be discarded.
4. There is a blast shield on the laser. If this needs to be replaced during a case, the fiber that is being used is discarded because you can't be sure that the fiber has caused this.

Fiber failure can cause injury to staff/patient, but in this case there was no adverse outcome.

Device: Mesh, Hernia
Manufacturer: Davol, Inc. Sub. C.R. Bard, Inc.
Brand: Bard Composix Kugel Hernia Patch Small Oval
Lot #: 43LQD184

Problem:
Patient had ventral hernia repair with insertion of mesh. Patient had continued tenderness RLQ and bulge. Mesh removed after a few months, with re-repair of ventral hernia and new mesh inserted.

See recall online available at: http://www.fda.gov/cdrh/recalls/recall-122205.html. Also see May’s Medical Device Problem Summary describing adverse events with hernia mesh.

Device: Sternal Saw Hose
Manufacturer: ConMed Linvatec Hall Surgical
Brand: Hall Sternum Saw
Model #: 5052-10

Problem:
Midline sternotomy was made from the sternal notch to the xiphoid process. Approximately halfway through the sternum with the sternal saw, the pressure line to the sternal saw exploded. Pressure setting for saw was set at 150 psi via nitrous pressure control valve. There was one small piece of rubber on the upper portion of the drapes which was removed and this area was covered with sterile towels just to ensure sterility. In addition, the patient was given 1 g of vancomycin intravenously at this point in time just as a precaution. A new saw was used to finish the sternotomy. Rest of procedure completed without further incidence. Patient was taken from the operating room to the cardiovascular recovery room in stable condition.


PHYSICAL MEDICINE

Device: Bed, Low Air Loss
Manufacturer: Kinetic Concepts, Inc. (KCI)
Brand: Kinair Medsurg
Model #: KinAir MedSurg
Cat #: 201001W

Problem:
Rails fully raised. Pt head trapped under upper left side rail and caught between siderail and inflating KinAir MedSurg air mattress. Bed head deck section raised ~10-20 degrees. Pt did not sustain injury.
======================
Manufacturer response for air flotation, low air loss support surface bed, KinAir MedSurg
======================
No response. Have requested entrapment zone testing data from them on this bed. They have not provided.

Device: Specialty Air Bed
Manufacturer: Kinetic Concepts, Inc.
Brand: Kinair

Problem:
Critically ill patient with multiple skin tears, decubiti (DQ's) on buttocks and coccyx, on KCI specialty air bed Kinair. Bed placed on instaflate and patient turned to side to wash back and place zenaderm on her DQ's. Bed in locked position, however bed was not locked and moved. Patient's leg fell off side of bed and hit lower side rail. Unable to get bed to lock even though the brake was on. More staff called in to help and hold bed while trying to finish getting patient cleaned up. Right leg now has a very deep skin tear to shin, adipose tissue visible, area appears to be developing a bruise on area that hit the side rail. KCI called to have someone come fix the bed. The person who answered the 1-800 number acted like she had never heard of our hospital and informed me she did not have any beds in use at our hospital. Staff called hospital central supply who coordinated via other means to get a KCI rep on-site. From KCI: staff were informed that the wheels have to be in a certain position in order for the bed to lock, and staff was not aware of this. Once the KCI rep informed staff of this, they were able to get the bed to lock. This is not a common bed used in the ICU. The caster wheel on the right side must be parallel to bed frame to lock into position. ICU staff requested an information card be placed on beds for safety reasons. Patient leg required sutures to close open skin tear.
======================
Manufacturer response for Specialty Air Bed, Kinair
======================
KCI rep to arrange to have staff in-serviced ASAP.

Device: Treadmill
Manufacturer: Woodway
Brand: Treadmill
Model #: DESMOM

Problem:
Patient completed training on the treadmill. The treadmill was switched to the "off" position. Physical Therapist stepped off the treadmill in order to prepare for patient to come off while the patient held onto the rails of the treadmill. At that point, the belt of the treadmill lunged backwards, causing the patient to fall on his buttocks while he still held onto the rails. After initial assessment of pain, at the sacrum, the patient was assisted to a chair for rest.

In our discussions with the manufacturer, they have informed us that there is a modification to stop the belt from 'free-wheeling' when power is off. Our facility was sent parts to install, but it did not fix the unit. We are in the process of coordinating a factory repair.
Device: Cold Therapy Unit
Manufacturer: BREG, Inc.
Brand: Polar Care
Cat #: 04790

Problem:
The Polar Care unit with the universal pad was placed directly on the patient's skin (right knee) and then wrapped in place with gauze. When the patient complained of pain at the site, the RN removed the dressing and polar care pad and discovered that blisters had formed along the incision line. Three blisters were noted measuring 13cm long x 5cm wide, 3cm x 2cm, and 3cm x 2.5cm. The MD was notified, Polar Care unit discontinued, and non-adhesive gauze dressing applied. Hospitalization was not extended. Pt's skin is dry and fragile. No lotion was on the pt's skin--polar care unit was applied directly to the skin without a barrier in place. The device insert and the device itself are clearly marked to indicate that a barrier should be used. The cooling unit as well as the pad both contain warnings to use a barrier with the device.

Device: Heat Pack
Manufacturer: Hospital Marketing Services Co., Inc
Brand: Novaplus Instant Warm Pack
Cat #: V6001-043

Problem:
Patient reported to RN that she was burned from the warm pack that was placed on her left arm prior to an IV start. RN noted the area was red with slight elevation, but no blistering. Patient complained of discomfort. MD notified--no change in management plan. No medications required to treat reddened area. RN noted that the warm pack had been applied directly to the skin and that the hot pack cover had not been applied.

This heat pack is a relatively new product to our facility. The previous product did not require a cover or sleeve--this new product does. Staff applied the heat pack without the sleeve, although the packaging clearly indicates that a towel or soft cover should be wrapped around the heat pack before application.


NEUROLOGY

Device: Shunt, Central Nervous System and Components
Manufacturer: Medtronic Neurosurgery
Brand: Ventricular Shunt Catheter
Lot #: A77305
Cat #: 27782

Problem:
The patient was admitted to the O.R. with a shunt malfunction. A 5 cm shunt catheter was found to be disconnected from the shunt catheter base. The base was removed, but the catheter was disconnected in the brain.

On the ultrasound, the catheter could be seen; it was about 1 cm into the brain. Clinician followed the previous track and looked down carefully to the hole, but could not find any evidence of the shunt, could not palpate the shunt. Therefore, the search for the catheter was abandoned.

Our facility has identified 7 cases, to date, of this unusual mode of failure. Our site has switched to a line of ventricular shunts that do not have the BioGlide coating (we are concerned that the BioGlide coating on these ventricular shunts may compromise the bonding between device components, thus causing the disconnection).

In our discussions with the manufacturer, our site learned that Medtronic has issued a voluntary recall on the Bioglide Ventricular shunt catheter product # 27782.

See recalls online available: http://www.fda.gov/cdrh/recalls/recall-021209.html and at: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1238091091955&lang=en_US


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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Surgical Mesh Products for Hernia Repair

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Surgical mesh is a polymeric, biologic or metallic screen intended for implant to reinforce soft tissue or bone where weakness exists. It is typically used in surgery for the repair, reconstruction, or substitution of tissue, commonly in hernia repair surgical procedures.

Over the past 2 years, MedSun has received 29 adverse event reports associated with 30 hernia mesh products in 30 patients. The reports were submitted by 20 hospitals between February 2007 and April 2009. The most frequently reported device problems were:

• Mesh explanted due to recall (6 reports)
• Ring breakage (4 reports)
• Mesh tear (4 reports)
• Defective mesh (3 reports)
• Mesh perforation (3 reports)
• Adhesion issue (2 reports)
• Mesh erosion (2 reports)

None of the reports involved a patient death. Common patient injuries listed below were reported in 15 of these 30 patients. Note: more than one patient injury can be assigned to each report.

• Additional surgical procedure required (18 reports)
• Infection (5 reports)
• Abscess (4 reports)
• Pain/soreness (3 reports)
• Inflammation/swelling (3 reports)

All reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 20 reports involved female patients and a total of 10 reports involved male patients.

MedSun reports contributed to FDA awareness of these device problems. Complications have been reported with a range of hernia mesh manufacturers, a majority of which are associated with the use of Composix Kugel Hernia Patches manufactured by Davol Incorporated, a subsidiary of C.R. Bard. The Bard Composix Kugel Extra Large Oval Patches were first recalled in December 2005. This Class I recall was expanded two times after the original recall notice, first in March 2006 and again on January 24, 2007, which ultimately recalled all product codes and lot numbers belonging to the Bard Composix Kugel Mesh Patches.

In October 2008, the FDA updated its safety information on hernia mesh repair.

Although the vast majority of reports were related to the recalled meshes, MedSun continues to see reports discussing adverse reactions with the recalled mesh, as well as with other mesh products. FDA continues to analyze and evaluate incoming reports about issues with all hernia mesh products.

[Note: The reports have been edited for clarity]




MedSun Surgical Hernia Mesh Adverse Event Reports Received Between February 2007 and April 2009
Device Manufacturer Device Identifiers Event Description
Covidien United States Surgical Corporation Parietex Composite (PCO) Model: PCO15 Lot: P1F00935The patient had a ventral hernia repair. 21 days later, the patient returned for recurrent ventral hernia repair to replace the mesh. The surgeon stated that the mesh was "destructed from suture” and the mesh was stuck to the bowel.
Davol Inc. A subdivision of C.R. Bard, Inc.
Kugel Bard composite mesh
Hernia mesh failed and resulted in infection. Patient has a history of a ventral hernia for which she has suffered chronic infected mesh. She has undergone multiple abdominal wall surgeries since that time.
Davol Inc. A subdivision of C.R. Bard, Inc.
Kugel Composix 10.7x13.7cm
Large piece of Bard Kugel Composix mesh was explanted from the patient. The explanted mesh was part of the recall. Patient experienced chronic hernial infection, located inferior to mesh.
Davol Inc. A subdivision of C.R. Bard, Inc.
Bard Composix mesh
Bard Kugel Composix mesh was explanted from the patient per nationwide recall.
Davol Inc. A subdivision of C.R. Bard, Inc. Bard Composix Kugel Hernia Patch Small Oval
Lot: 43LQD184
Mesh implanted to repair ventral hernia. Patient experienced continued tenderness and bulging to the Right Lower Quadrant (RLQ). Mesh was removed after a few months, with re-repair of ventral hernia and insertion of new mesh.
Unknown Composix Mesh
Patient had mesh implanted many years ago at a different facility to repair ventral hernia. Patient has had hernia reoccurrence despite having mesh implanted. Patient has also experienced a chronic abdominal wound, which was packed.

This patient was seen at our facility with purulent drainage from wound, despite packing. Patient was found to have an exposed and infected mesh. Patient went to the Operating Room for an exploratory laporoscopy where we performed the following: removal of infected mesh, removal of old packing, drainage of marsupialized cavity, and closure with Permacol mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Bard Composix Kugel Mesh Patch
Lot: 43APD292
Cat: 10207
Patient had partial small-bowel obstruction secondary to adhesions that resulted in multiple hospitalizations and required surgery. At the time of surgery, during the dissection of the adhesions to the anterior abdominal wall, the left lateral inferior portion of the prosthesis was found with a fracture to the periphery of the supporting ring. The prosthesis was adherent to loops of small bowel.
Davol Inc. A subdivision of C.R. Bard, Inc. Kugel Hernia Patch
Lot: 43KMD157
Cat: 10105
The patient was brought to the OR for explantation of a MRSA-infected Kugel hernia patch, which had been implanted a few years ago. We excised the abdominal wall mesh and repaired the resultant epigastric defect with a 20 x 10 cm Permacol mesh.
Bard Access Systems Composix Kugel
Lot: 43CND224
Cat: 10202
Recoil ring breakage of Kugel Mesh (used for hernia repair) caused abscess to patient's abdominal wall.
Lifecell Corp Alloderm 6x16cm
Lot: NR: B20904-047
The alloderm product used for hernia repair had ruptured.
Ethicon, Inc. Proceed
Lot: ZLG767
Other: PCDG1
This patient had a hernia repair for three ventral and one umbilical hernia (all three ventral hernias and the umbilical hernia were connected into one large hernia). An approximate 5 X 7 piece of PROCEED mesh was used for this repair. The mesh was placed as an underlay and secured circumferentially with transfascial 0 Prolene sutures. A total of eight sutures were used to secure the PROCEED Mesh. Care was taken to identify the bowel throughout the entire procedure. The physician noted that the patient tolerated the procedure well without complication and was taken to the recovery room in satisfactory condition.

The procedure was done as a same-day-surgery procedure. When at home later that day, the patient developed nausea and vomiting. On the third post-op day, the patient was seen in the Emergency Department with a chief complaint of abdominal pain, nausea/vomiting, and abdominal distention. The patient had not passed any gas or had any bowel movement after the surgery. A CT scan demonstrated that a loop of small bowel incarcerated in the incisional ventral hernia repair. The patient was brought back in for surgery. The physician noted that the etiology of the incarceration was due to the fact that three of the eight transfascial sutures had pulled through the mesh. To remedy the situation, the entire mesh was removed and replaced with a new piece of mesh. The patient tolerated the procedure without complication and was discharged to home five days post-operation.
LifeCell Corporation AlloDerm Regenerative Tissue Matrix
Other: 402025
Patient underwent resection of pilocytic astrocytoma in the posterior fossa. The hospital course was uneventful and the patient was discharged a few days later. The patient returned the next day with fever and pain. The patient was admitted and treated with antibiotics. Cerebrospinal fluid culture revealed an enterobacter aerogenes infection. Nine days later, the patient returned to surgery. There was minimal collection of purulent material in the epidural space; however there was significant collection in the subdural space. The graft to the dura was removed and a new graft from the periosteum was sewn into place.
Tissue Science Laboratories Permacol 15 x 20cm x 1.0mm
Model: REF 101520
Lot: 07B01-9
Patient returned to the Operating Room (OR) for bowel perforation and adhesions. The surgeon dictated in his surgical report that the mesh that had been implanted the previous week had, under pressure, split in the mid-portion. The mesh was removed and none was replaced.
Davol Inc. A subdivision of C.R. Bard, Inc. Kugel Composix
Model:10208
Lot:73COD293
Cat:10208
The patient complained of periumbilical pain and requested that the recalled mesh be removed.
Bard Urological Division Avaulta Solo Synthetic Support System
Lot: CVRK0018
Cat: 486200
Bard Avaulta Solo Posterior Synthetic Support System Mesh tore when being applied. Surgeon was able to complete the procedure with the remainder of the mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel Mesh
Lot: HURB3676
Other:10206
Patient had dehiscence of ventral herniography with surgical mesh. Patient returned to surgery for repair. Operative Note: Patient noted in Recovery Room (RR) to have disruption to the lower part of ventral abdominal hernia repair. Bard composite graft was attached three fourths of the way around his ventral abdominal wall defect. However, distally in the lower part of the incision, the 1-0 Prolene horizontal mattress sutures were disrupted, as were the staples. The Bard composite graft and the staples achieved very poor mesh adherence to the abdominal wall. Surgeon increased the length of the Bard composite graft by sewing another piece of Bard composite graft to the ventral aspect to the largest of the Bard composite graft that was previously implanted.
Davol Inc. A subdivision of C.R. Bard, Inc. None
Mesh removed.
Composix Abdominal mesh
Defective Gortex mesh. Patient had undergone 3 or more incisional hernia repairs with a low transverse abdominal incision, initially made for acute diverticulitis. The patient had a painful bulge in the lower left abdomen and a recurrent hernia on the right lower abdomen, due to failure of the Gortex mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel
Lots: 43GPD434 & 43KOD267
Cat: 10202
Two events involving the same brand (two different lots) of the Kugel hernia mesh. Both lots of the mesh were recalled via a Class I recall in January of this year (2007). The first patient was initially treated for a gunshot wound to the abdomen and developed an incisional hernia, which were repaired with a Kugel patch prior to release of the recall. He recently presented with a recurrent incisional hernia at the 9 and 10 o'clock position. The doctor removed the patch and replaced it with another brand of mesh.

The second patient had a laparoscopic nephrectomy done by a hand-port incisional hernia. The defect was initially repaired with a Kugel mesh device. Approximately a year post-operation, the patient gained 30 pounds and had a reoccurrence of the previous hernia.
Bard Urological Division Pelvicol Acellular Collagen Matrix
Lot: 06B15-1
Other: Reorder No: 482812
Patient with complication (abscess and inflammation) at site of previous surgery where mesh was implanted. Per surgeon, the term "erosion" is what is used in ICD9CM, but is not very accurate. The abscess was cultured, no growth. The mesh was surgically removed 2 months later.
Bard Urological Division Pelvisoft Acelluar Collagen BioMesh
Lot: 06B15-9
Patient with complication (abscess and inflammation) at site of previous surgery where mesh was implanted. The abscess was cultured, no growth. The mesh was surgically removed 5 months later.
Bard Access Systems Bard Composix Kugel Hernia Patch
Lot: 43E0D214
Other: Ref 0010202
Incisional ventral hernia repaired with Bard Mesh, which eventually had to be removed due to defect.
Bard Access Systems Ventralex Hernia Patch
Lot: 43DQD395
Cat: 10302
Patient had a laparoscopic ventral hernia repair. According to the physician, the patient progressed postoperatively as expected, without complication. However, four days later, the patient's condition worsened and the patient had to undergo open surgery where two perforations were noted in the small bowel.
Bard Access Systems Composix Kugel Hernia Patch
Lot: 43EQD414
Cat: 10205
Patient had a laparoscopic ventral hernia repair last year. The patient progressed postoperatively as expected, without complication. However, four days postoperative, the patient's condition worsened and the patient had to undergo open surgery where two perforations were noted in the small bowel.

According to the physician, the Composix Mesh was removed and it was noted that the patch had not retained its oval shape. The patch appeared crumpled on both sides and had creases running along the center of the mesh, indicating that the ring had broken.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel
Model: 10206
Lot: 43APD431
The mesh was placed prior to the manufacturing recall. The patient was brought in for a bowel stricture procedure and, during this surgery, the mesh was identified. Because we were aware that this may have been a recalled mesh product, we called Davol, Inc./C.R. Bard and they confirmed that this was, in fact, a piece of mesh that had been recalled. It was decided that we would remove the mesh, just to be safe.
Bard Access Systems Composix Kugel
Lot: 41ELDP27
Other: REF 0010204
Patient had a bowel obstruction from an incarcerated hernia placed late last year. During that repair the midline incision divided the mesh, which was repaired with nylon. Patient developed a draining wound since that repair.
Ethicon, Inc. ProceedA six month extension was given by the company on outdated mesh. As surgeon was sewing the mesh to the abdomen, the mesh separated. This is not what the mesh is designed to do. The sales representative was notified. The mesh was removed from the patient's abdomen and a different type of (current) mesh was used. All other meshes were pulled from our shelves.

Excerpt from September 2006 Customer Letter:
“Dear Customer,
We are pleased to announce that we have successfully completed stability studies designed to extend the shelf life of PROCEED Surgical Mesh. The results of these studies allow us to expand current expiry dating for an additional six (6) months. This additional data allows for a 12-month shelf-life. An additional 6 months should be added to the date printed on the PROCEED Mesh package for any product currently on the market with an expiration date prior to and including March 2007 (2007 - 3). For example: Current Expiry Date New Expiry Date (October 10, 2006) (April 4, 2007) (February 2, 2007) (August 8, 2007) Any product with an expiry date of April 4, 2007 or LATER reflects the new expiry dating and should be used by the date printed on the package. For example: Current Expiry Date New Expiry Date (April 4, 2007) Date printed on package (Sept 9, 2007) Date printed on package If you have any questions regarding the expiry dating of any PROCEED MESH product, please contact your sales representative.”
Davol Inc. A subdivision of C.R. Bard, Inc. Collamend Implant
Lot: DARA0082
Cat: 1175104
The Sigmoid colon resection was complete and they were suturing the abdomen. The mesh began to spontaneously split as they were suturing. The surgeon did not touch the mesh or cut it in any way. The mesh had to be removed which extended the length of the surgery.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel Hernia Patch 11.4 cm x 11.4 cm
Lot: 43DOD281
Other: REF 0010204
Patient experienced tenderness and continued bulging at graft placement site to reduce a hernia.

Additional Information:

Class I Recall: Bard Composix Kugel Extra Large Oval Patches. FDA Recall. January 24, 2007.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062944.htm

FDA Safety Information on Hernia Mesh Repair. October 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm#hernia

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Updated May 1, 2009

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