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U.S. Department of Health and Human Services

MedSun: Newsletter #47, April 2010

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Newsletter #47, April 2010

Articles

Boston Scientific Implantable Cardioverter Defibrillators: Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals that FDA has been notified by Boston Scientific that it has stopped shipment and started recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted.

FDA is advising practitioners that they should not use these devices unless and until the agency reviews and approves the changes the company has made. FDA is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted.

Additional Information:

FDA MedWatch Safety Alert. Boston Scientific Implantable Cardioverter Defibrillators: Recall. March 19, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205409.htm

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Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class 1 recall of certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products, including Numerous Products Containing the Q-Syte Luer Access Split Septum Device, Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.

The affected BD products were distributed from August 1, 2008 through February 1, 2010. These lots of the BD Q-Syte Luer Access Split Septum devices are defective, which may result in: air bubbles leaking into the infusion system and into the patient’s bloodstream, leakage of therapy being infused and result in incomplete inadequate administration of therapy, and a potential for blood leakage through this defect.

Additional Information:

FDA MedWatch Safety Alert. Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall March 18, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205098.htm

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Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall

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FDA MedWatch Safety Alert

FDA and Gyrus ACMI notified healthcare professionals of a Class I recall of Gyrus ACMI Micron Bobbin Vent Tube T, 1.27 mm. Units of the product in lot number MH136952 have been shipped without being sterilized. This product was manufactured only on December 17, 2009 and distributed only on December 22, 2009. Patients should contact their physicians to discuss symptoms that may result from use of the affected products.

Additional Information:

FDA MedWatch Safety Alert. Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall. March 17, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204992.htm

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Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall

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FDA MedWatch Safety Alert

Teleflex Incorporated notified healthcare professionals of the recall of all lots of Arrow Select IV Tubing Sets, accessories, and certain lots of arterial embolectomy catheters because it has been determined that product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged, and if product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death.

Additional Information:

FDA MedWatch Safety Alert. Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall. March 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204532.htm

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Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Initial Communication

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FDA Medical Device Safety

Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers’ polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. The product codes, sizes and lot numbers of the counterfeit product identified, to date, are noted in the Initial Communication linked under Additional Information below. Recommendations and actions for healthcare professionals, healthcare facilities, and patients are also provided.

Additional Information:

Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Initial Communication. FDA Medical Device Safety. March 11, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204224.htm

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Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class 1 recall of Torflex Transseptal Guiding Sheath, a medical device used to pass heart catheters from the right to the left side of the heart. The sheath tip may break off and separate during heart procedures. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart.

Additional Information:

FDA MedWatch Safety Alert. Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall. March 11, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204177.htm

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Beckman Coulter UniCel DxC Synchron Clinical System - Ion Selective Electrode Flow Cell: Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class I recall of UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell. There may be excessive build-up of protein, bacteria, and sample tube additives in the instrument's ion selective electrode flow cell which may cause incorrect sodium results.

Additional Information:

FDA MedWatch Safety Alert. Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall. March 11, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204106.htm

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Abiomed AB5000 Circulatory Support System: Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class 1 recall of the AB5000 Circulatory Support System, a product that supplies power to disposable blood pumps used to support the left and/or right sides of the heart. The computer may shut down (stop pumping) without an alarm and this defect may cause serious injuries or death.

Additional Information:

FDA MedWatch Safety Alert. Abiomed AB5000 Circulatory Support System: Class I Recall. March 10, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203956.htm

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Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall

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FDA MedWatch Safety Alert

FDA and Thomas Medical Products notified healthcare professionals of a Class I recall of the Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit), which are prescription medical devices used to pass heart catheters from the right to the left side of the heart. The sheath tip may break off and separate during heart procedures. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart. This could lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death.

Additional Information:

FDA MedWatch Safety Alert. Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall. March 5, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203272.htm

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StatSpin Express 4 Centrifuges Model 510: Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of the StatSpin Express 4 Centrifuges, Model #510, Serial Numbers 00100 through 001679, manufactured and distributed from November, 2007 through January, 2010. The rotor of the centrifuge may break and separate from the motor, striking a safety microswitch so it fails to shut down the centrifuge. The loose rotor may strike the lid of the centrifuge housing which may cause the lid to open and eject pieces of the rotor.

Additional Information:

FDA MedWatch Safety Alert. StatSpin Express 4 Centrifuges Model 510: Recall. February 26, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202169.htm

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CDRH Event Problem Codes

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FDA Medical Device Safety

This website contains enhanced device and patient problem codes. Please use this information to become familiar with the improved Event Problem Codes. April 2, 2010 is the target date to reject all inactivated and retired codes.

Additional Information:

FDA Medical Device Safety. CDRH Event Problem Codes: Online Available. Last updated January 6, 2010.
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/EventProblemCodes/default.htm

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KidNet

MedSun's KidNet Promotes Neonatal and Pediatric Patient Safety

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By: Suzanne Rich, RN, MA, CT
MedSun/OSB Division of Safety Partnerships

KidNet is a specialty subnetwork of FDA's Medical Product Safety Network (MedSun). It focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric patient populations, especially those occurring in neonatal and pediatric intensive care units (NICUs and PICUs).

Currently, 42 MedSun hospitals are participating in KidNet. Just over half of these are MedSun pediatric hospitals; the rest are MedSun hospitals with NICUs and PICUs. We launched KidNet in June 2007. Although the focus of KidNet is on device-related adverse events occurring in the NICU or PICU, reports of events occurring in other areas of the hospital involving neonatal or pediatric patients are both welcome and encouraged.

For calendar year 2009, MedSun received 147 reports involving pediatric patients (those with ages listed as less than 21 years) from all clinical areas in MedSun KidNet hospitals. Of these, 62 reports were marked as KidNet or the event location was marked as NICU, PICU, or critical care. The data discussed in this article are derived from these 62 reports.

 This bar graph illustrates the number of KidNet reports received by quarter.  These reports were submitted by KidNet participant sites over the 2009 calendar year.  The 62 KidNet reports have been grouped by quarter (1st quarter, 2nd quarter, 3rd quarter, 4th quarter). The x-axis corresponds to quarter; the y-axis corresponds to the number of reports.  Left to right description of image: of the 62 KidNet reports received in 2009, the light purple data point shows that 28 KidNet reports were received in the 1st quarter.  The burgundy data point shows that 17 KidNet reports were received in the 2nd quarter.  The yellow data point shows that 23 KidNet reports were received in the 3rd quarter.  The tallest data point, depicted by a light blue bar shows that 14 KidNet reports were received in the 4th quarter.
*Figure 1: 2009 KidNet reports by quarter

As part of the larger MedSun network, KidNet emphasizes the importance of recognizing and reporting device related adverse events associated with patient, family member, or healthcare provider death or serious injury, and in recognizing and reporting problems representing ‘potential for harm’ and ‘close call’ events. The majority of reports from KidNet in 2009 involve device-related problems described as minor harm, potential for patient harm, or close call events. Three reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury), and one report is associated with a patient death.

This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2009.  The 62 reports are categorized by event type, specifically by the categories of:  product problems, serious injury, and death.  Of the 62 reports, 58 reports were submitted as product problems, depicted by a light purple pie wedge.  3 reports were submitted as serious injury and 1 report was submitted as death, which is depicted by burgundy and yellow pie wedges, respectively.
*Figure 2: 2009 KidNet reports by event type

The three reports describing serious injury events (those requiring medical or surgical intervention taken to prevent permanent impairment or damage) involve an umbilical vein catheter, a drug wound dressing, and an oxygenator used in extracorporeal membrane oxygenation (ECMO). The event involving a leaking umbilical vein catheter describes the catheter snapping when it was removed by a healthcare provider, which requiring intervention to remove the retained device. The event with a drug wound dressing involves an infant with a tracheotomy who experienced increasing respiratory distress. Emergent removal of the tracheotomy device plug at the bedside with anesthesiology present resulted in the identification and removal of absorbable dressing found within and around the tracheotomy stoma resulting in immediate improvement of symptoms. The event associated with a membrane oxygenator involves a patient experiencing severe hypotension after being placed on ECMO when the temperature probe port on the top of the membrane oxygenator of the ECMO circuit fractured with blood escaping from the circuit. Manual resuscitation and ventilation including cardiac massage was undertaken until the membrane oxygenator could be replaced, the ECMO circuit restarted, and patient transfer to PICU was accomplished.

The event associated with a patient death involves a patient initially admitted for low intracranial pressure (ICP) and headaches who went to the operating room for insertion of a parenchymal bolt intracranial monitoring device. After receiving medication for pain, the patient became apneic and stopped breathing with pupils becoming fixed and dilated. The patient was intubated and the intracranial monitoring device was checked and adjusted. Upon confirmation of proper placement, the subsequent intracranial pressure reading was high. Despite extensive brain resuscitation, the patient’s parents requested that care be withdrawn, and the patient died.

The 62 KidNet reports reference 66 devices, of which there are 31 different types. The number of devices is greater than the number of reports as more than one device may be referenced in a report. The 31 reported device types have been grouped by clinical medical specialty as defined in the listing below for the chart that follows.

(1) IV devices – PICCS, ports, central venous catheters, umbilical catheters, IV tubing, pumps

(2) AN/Respiratory products – anesthesia mixers, ventilators, ventilator tubing, oximeters, respiratory humidifiers, and tracheotomy tubes

(3) CV/Neurology devices - EKG electrodes, cardiopulmonary bypass devices, blood pressure monitor transducers, external pacemakers, intracranial pressure monitors

(4) GI/GU products – enteral infusion pumps, feeding tubes, urethral catheters, urine collectors

(5) All others - thermometers, illuminators, over the counter blood glucose monitors, drug wound dressings, circumcision clamps

This bar graph illustrates the number of reported medical devices by type in 2009 KidNet reports. The 66 devices reported have been grouped by clinical medical specialty. The x-axis corresponds to type of device; the y-axis corresponds to the number of devices reported.  Left to right description of image: of the 66 devices reported in 2009, the tallest data point, depicted by a light purple bar, shows that 26 reports involve Intravenous (IV) devices.  The burgundy data point shows that 19 reports involve Anesthesiology/Respiratory devices.  The yellow data point shows that 9 reports involve Cardiovascular/Neurology devices.  The light blue data point shows that 6 reports involve Gastroenterology/urology devices.  The dark purple data point shows that 6 reports involve All Other device types.
*Figure 3: 2009 KidNet reported devices by type

Reported patient demographics include patient age and gender, both of which were provided in 47 of the 62 reports. There are almost twice as many reports involving females than males.

This pie chart illustrates the number of 2009 KidNet reports that specify patient gender.  The 47 reports are categorized by gender, specifically by male and female.  Of the 47 reports, 17 reports involving male patients were submitted, which are depicted by a light purple pie wedge.  30 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.
*Figure 4: 2009 KidNet reports by patient gender

The patient ages provided in 47 of the 62 reports range from 2 days to 18 years with the majority of reported ages with patients less than 2 years old.

The chart below groups patient ages by the pediatric subpopulations specified in the Guidance for Industry and FDA Staff: Pediatric Expertise for Advisory Panels at http://www.fda.gov/cdrh/ode/guidance/1208.html.

This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2009 KidNet reports. The 47 reported patient ages have been grouped by pediatric subpopulations.  The x-axis corresponds to pediatric subpopulation; the y-axis corresponds to the number of patient ages reported.  Left to right description of image: of the 47 reported patient ages in 2009, the light purple data point shows that 20 reports involve newborn patients (0-30 days).  The tallest data point, depicted in burgundy, shows that 20 reports involve infant patients (30 days-2 years).  The yellow data point shows that 5 reports involve child patients (2 years-12 years).  The light blue data point shows that 2 reports involve adolescent patients (12-21 years).
*Figure 5: 2009 KidNet reported patient ages by pediatric subpopulation

Information on the device user at the time of the event was provided in 34 of the 62 KidNet reports with the nurse most frequently cited as the device user.

This pie chart illustrates the number of reports by device users - who was operating the device at the time of the event – in 2009 KidNet reports. Of the 62 KidNet 2009 reports, 34 reports indicate the device user.  Of the 34 reports indicating device user in 2009, the largest segment, in light purple shows that 21 reports specify nurses were operating the reported device at the time of the event.  The burgundy segment shows that 7 reports indicate that doctors were operating the reported device at the time of the event.  The yellow data point shows that 6 reports identify other allied health providers as the user operating the reported device at the time of the event.
*Figure 6: 2009 KidNet reports by device user


The goals of KidNet are:

(1) to improve the recognition, reporting, and understanding of device-related adverse events occurring with pediatric patients, especially those in NICUs or PICUs, and (2) to develop a clinical community to amplify signals of actual or potential medical device problems affecting NICU or PICU patients recognized by FDA or KidNet participants to facilitate timely interventions to address actual and potential device-related problems during clinical use.

This concept is based on collaboration and communication between FDA, KidNet participants, and device manufacturers, in order to better understand device safety and to identify solution and prevention strategies to address identified problems.

To this end, KidNet sponsored a webcast entitled, Peripheral IV and PICC Safety in Pediatric and Neonatal Patients in November of 2009. The webcast, featuring a speaker specializing in pediatric intravenous therapy from a MedSun KidNet hospital, described complications associated with peripheral intravenous (IV) catheters and peripherally inserted central catheters (PICC) used in pediatric and neonatal infusion therapy. Additionally, the role of human factors in peripheral IV and PICC catheter adverse events was discussed with strategies identified to address device related complications involving peripheral IV and PICC catheters.

Presentation slides and audioconference transcripts are available for this webcast, online available at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm206357.htm. Additional MedSun and KidNet programs are also available at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm112724.htm.

The following are 2 examples of neonatal and pediatric device-related problems reported through KidNet and MedSun in 2009 that represent just a few of the many successes from device-related problem recognition and reporting, information sharing, and solution strategy development by device users, FDA, and manufacturers working together to improve the safety of medical device use in neonatal and pediatric patients.

PICC Luer Hubs: Several reports were received from a MedSun KidNet site described events of cracking, leaking, breaks, and catheter occlusions related to cracking of luer hubs. The manufacturer had indicated that the problem was due to users over tightening the connections, a precaution listed in their instructions for use. MedSun follow-up with both the reporting site and the manufacturer prompted the firm to visit the site to better understand the reported events during clinical use. The manufacturer subsequently made materials and design changes in their product to address the reported events.

Infant Warmer: A report was received from a MedSun hospital involving a potential for harm event involving an infant warmer. Staff observed smoke and flame coming from the top of the warmer module cover while the unit was in the operating room pending delivery of an infant. The unit was in “pre-warm” mode but the infant was not in the bed. The biomed removed the top cover of the warmer module and observed one of the heater wires was detached. A manufacturer representative came to the facility to replace parts on the damaged unit and the heater elements on all of the other manufacturer’s units in the reporting facility. Follow-up with the manufacturer indicated changes were made to address the reported problem in both old and new units as part of a manufacturer recall.

If you become aware of problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended, or represent a potential for harm, please report these events through your MedSun representative if you’re a member of KidNet or MedSun, or through your hospital’s reporting policy. If you are not affiliated with a hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related adverse events a model for patient safety.

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Webcast: Peripheral IV and PICC Safety in Pediatric and Neonatal Patients

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Please visit the Educational Materials page for a newly posted webcast entitled, Peripheral IV and PICC Safety in Pediatric and Neonatal Patients sponsored by KidNet and presented in November of 2009. The webcast describes complications associated with peripheral intravenous (IV) catheters and peripherally inserted central catheters (PICC) used in pediatric and neonatal infusion therapy. Additionally, the role of human factors in peripheral IV and PICC catheter adverse events was discussed with strategies identified to address device related complications involving peripheral IV and PICC catheters.

Presentation slides and audioconference transcripts are available for this webcast. A direct link to this program may be found under Additional Information below.

Additional Information:

Peripheral IV and PICC Safety in Pediatric and Neonatal Patients. November 18, 2009. FDA MedSun Website: Educational Materials. Posted April 2010.
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm206357.htm

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LabNet

OneTouch SureStep Test Strips (LifeScan): Recall

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FDA MedWatch Safety Alert

LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. It is important that patients with recalled test strips continue to test their blood glucose.

Additional Information:

FDA MedWatch Safety Alert. OneTouch SureStep Test Strips (LifeScan): Recall. February 26, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm

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HeartNet

Take the Lead on Safety with Temporary Cardiac Pacing

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FDA Medical Device Safety

Temporary cardiac pacing is indicated for emergency treatment of some bradyarrhythmias and tachyarrhythmias, and prophylactically for patients at risk for brady - arrhythmias during cardiovascular surgery. Pacing lead wire disconnections, fractures, and misconnections are some of the problems known to be associated with temporary transvenous pacing leads. The following case examples were reported to the FDA through the medical device reporting program.

Additional Information:

FDA Medical Device Safety. Take the Lead on Safety with Temporary Cardiac Pacing. Dwyer, Diane; Bauer, Kelly. March 9, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm203731.htm

MedSun Report. September 26, 2009. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D3%3F%27%2FH%20%0A

MedSun Report. August 13, 2009. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2DO%3C%26%3F%5C%20%0A&CFID=35984629&CFTOKEN=e548de388c794210-9AE

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HomeNet

Webcast: Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home

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Please visit the Educational Materials page for a newly posted webcast entitled, Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home sponsored by HomeNet and presented in December of 2009.

The shift in care has moved from the hospital to the home and from clinicians to family caregivers and the patients themselves. Advances in medical device technology have been able to support this trend. This webcast describes the unique considerations that providers and patients should be aware of when receiving care in the home, provides examples of device-related incidents likely to occur in the home setting and encourages staff to report them.

Presentation slides and audioconference transcripts are available for this webcast. A direct link to this program may be found under Additional Information below.

Additional Information:

Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home. December 9, 2009. FDA MedSun Website: Educational Materials. Posted April 2010.
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm205691.htm

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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

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

Additional Information:

FDA Medical Device Safety. Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way. Last updated March 12, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064705.htm

FDA Medical Device Safety. FDA Public Health Notification: Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change. Last updated February 2, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062068.htm

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Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall

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FDA MedWatch Safety Alert

FDA and Baxter notified healthcare professionals of a Class I recall of the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems, which are prescription medical devices used to treat pediatric and adult patients with kidney failure. Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, and others.

Additional Information:

FDA MedWatch Safety Alert. Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall. March 3, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202885.htm

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SightNet

Preventing Corneal Burns during Phacoemulsification

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Pennsylvania Patient Safety Authority

None of the reports of thermal injury received by the Pennsylvania Patient Safety Authority suggested a failure of either the phacoemulsification unit or the probe used for the procedure. There is also no information indicating that corneal burns are more frequently associated with a particular phacoemulsification model. Any phacoemulsification system can cause thermal lesions. Surgical staff should be alert to any condition that could reduce delivery of saline, which cools the probe used to extract the lens. This article identifies several conditions known to reduce saline delivery and provides risk reduction strategies for avoiding these conditions.

Additional Information:

Pennsylvania Patient Safety Authority. Preventing Corneal Burns during Phacoemulsification. March 7, 2010.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Mar7(1)/Pages/23.aspx

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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 January 1 through January 31 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device:

Type: Co2 Detector
Manufacturer: Covidien Nellcor
Brand: Easy-cap Ii
Model#: (not provided)
Lot #: 7334108
Cat #: (not provided)
Other #: (not provided)

Problem:
Burn patient required intubation. Burn MD intubated patient and used a Nellcor Easy Cap II Co2 detector to determine if tube was properly inserted and patient was correctly intubated. Co2 detector did not change color to indicate proper ventilation of patient. MD retracted the tube, thinking the tube was incorrectly placed and then reapplied the Co2 detector again to check for proper ventilation. Again, the detector did not change colors as it should. MD tried once more with the same result, no change in detector color. At this point the MD asked for and used another Co2 detector which quickly changed color to indicate proper ventilation of the patient. After the third intubation and patient was secured, MD questioned if the Co2 detector was defective. MD felt the multiple intubations (3) did cause some additional swelling to patient’s airway. Patient remained intubated in unit recovering from her severe burns.


Device:

Type: Oscillator Vent
Manufacturer: CareFusion SensorMedics
Brand: Sensormedics 3100b
Model#: 3100B
Lot #: (not provided)
Cat #: 3100B

Problem:
Patient was being treated with the oscillator vent when it was reported by an anonymous user that during a patient handoff, the patient coughed and the surround/diaphragm speaker had blown out. The disposables were not sequestered. There was no patient harm. The patient was placed onto a ServoI vent in response to the equipment failure. We have sequestered the vent and have begun to investigate the complaint and initiate a repair.

Manufacturer response (as per reporter) for Oscillator Vent, Sensormedics 3100B

They have had a large number of these failures recently. They are questioning cleaning chemicals and have seen a sharp increase in failures with H1N1. They may change their spec to require premature replacement of the driver component and reduce their spec from 4000hrs to 2000hrs.


Device:

Type: Tracheostomy Tube, Disposable Cannula, Low Pressure, Cuffed
Manufacturer: Covidien Shiley
Brand: Shiley Dct8 Cuffed
Model#: 8 DCT (size)
Lot #: 0903001434
Cat #: CE0123
Other #: (not provided)

Problem:
Approximately 3 hours after initial tracheostomy, audible leak was heard from trach site. Respiratory Therapist attempted to correct the leak and patient then returned to the OR for replacement of Trach tube with new size 8. This was the 6th tracheostomy tube with leak (4/6 with ruptured balloon) since August 2009. Issue previously reported to MedSun. The 4/6 trach tubes were from same Shiley size # 8 Lot size and remainder of stock from this lot have been removed from shelf. Manufacturer aware.

Manufacturer response (as per reporter) for Disposable cannula low pressure cuffed tracheostomy tube, Shiley:

Manufacturer reached out to the local Shiley representative and requested he contact the hospital.


Device 1:

Type: Vapotherm Patient Circuit
Manufacturer: Vapotherm Inc.
Brand: Vapotherm Patient Circuit
Model#: PF-DPC-LOW
Lot #: 09120710350
Cat #: PF-DPC-LOW
Other #: (not provided)

Device 2:

Type: Vapotherm Patient Circuit
Manufacturer: Vapotherm Inc.
Brand: Vapotherm Patient Circuit
Model#: PF-DPC-LOW
Lot #: 09112510307
Cat #: PF-DPC-LOW
Other #: (not provided)

Problem:
When patient circuit was attached to the filter box of a Vapotherm Precision Flow humidifier it did not click in so it came loose and it leaked water. The event was discovered because of water leaking from the connection onto the floor. The only way we could have prevented it was to make sure the circuit is completely pushed in and the clip that holds the circuit clicks in, but staff does not feel this would totally fix the problem.

Manufacturer response (as per reporter) for Vapotherm Patient Circuit, Vapotherm Patient Circuit

Manufacturer provided RGA# for product return evaluation.


CARDIOVASCULAR

Device:

Type: Catheter, Ablation, Rf, Cardiac
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Model#: (not provided)
Lot #: 15002294
Cat #: NI75TCFH
Other #: (not provided)

Problem:
Carto imaging of the catheter tip was backwards. The catheter was wired improperly. The catheter was replaced with a new one and the problem was resolved. The replacement packaging from the second catheter was not saved for lot comparison. There was no injury to the patient. This is the first time we have seen this type of problem.


Device:

Type: Catheter, Arterial, Radial
Manufacturer: Teleflex Medical
Brand: Radial Artery Catheterization Set
Model#: (not provided)
Lot #: CF8096562
Cat #: RA-04122
Other #: (not provided)

Problem:
The anesthetist was attempting to place a radial artery catheter in a child. The artery was not cannulated but as he tried to remove the catheter he was unable to withdraw the device from the patient. Eventually most of the device withdrew but approximately 1 inch of the catheter containing the broken wire was retained in the patient. The catheter broke off at skin level and part of the catheter and stylet were retained under the skin. The surgeon did a small cut-down to remove the retained arterial catheter and stylet.

A second kit of the same lot number was opened to make a second attempt at placement. It was examined before the attempt and found to be defective. Withdrawing the stylet wire from the needle resulted in approximately 1 inch of wire left protruding from the needle. This kit was not used on the patient.


Device:

Type: Defibrillator, Crt
Manufacturer: Medtronic Inc.
Brand: Concerto
Model#: C154DWK
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient has a history of nonischemic dilated cardiomyopathy with severely depressed left ventricular systolic function (most recent EF 25% to 30% on echocardiogram one and a half years ago), chronic left bundle-branch block with QRS duration of 148 milliseconds and New York Heart Association class III heart failure symptoms (historically). She underwent implantation of a Medtronic dual-chamber, biventricular ICD over three years ago. Her right ventricular (RV) and left ventricular (LV) lead thresholds were noted in time to be significantly elevated, requiring high-output pacing. Additionally, her Medtronic Concerto CRT-D reached premature elective replacement interval but does not appear to be part of the recent recall. Her right ventricular lead was Sprint Fidelis, model 6949, and was noted on routine follow up to have decreased sensing, in addition to elevation in thresholds. Her LV lead was in the anterior interventricular branch pacing the anterior septum. She presented for lead revision and new generator placement. There was no injury to the patient.


Device 1:

Type: Defibrillator, External
Manufacturer: Philips Medical Systems
Brand: Heartstart Xl
Model#: M4735A
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Paddles, Switched, Defibrillator, Internal
Manufacturer: Philips Medical Systems
Brand: (not provided)
Model#: M4743A
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The OR staff report there was a patient in the OR for chest re-exploration. As the chest was opened, the patient converted to ventricular fibrillation. Internal chest paddles were connected to the machine and they would not fire. The doctor tried multiple times and the paddles would never fire. The paddles were replaced and still could not get a new set to fire. The defibrillator machine was replaced with another Philips HeartStart XL and finally able to get a charge across the heart using the second set of paddles. There was no delay in maintaining perfusion as the patient was intubated and maintaining blood pressure with anesthesia assistance. The surgeon was massaging the heart for "maybe two minutes" until the defibrillator worked and was able to proceed. The unit and paddles were removed from service and sent to Clinical Engineering. The unit and paddles will NOT be placed back into service. The patient had successful surgery with bleeding of heart stopped and was sent to ICU/CVCU. He was then weaned from the vent and was maintaining good hemostasis as well as being alert and oriented. The patient continued to do well and was discharged home. The defibrillator and both sets of internal paddles were tested in biomed per manufacturer and passed. No error messages were noted on the error log of the defibrillator and there was never a message displayed that the internal paddles were not connected.


Device 1:

Type: Lead, Defibrillation
Manufacturer: Medtronic Inc., Cardiac Rhythm Disease Management
Brand: Sprint Fidelis
Model#: 6949
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Lead, Left Ventricular
Manufacturer: Medtronic Inc., Cardiac Rhythm Disease Management
Brand: Attain Otw
Model#: 4194-88
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient has a history of nonischemic dilated cardiomyopathy with severely depressed left ventricular systolic function (most recent EF 25% to 30% on echocardiogram one and a half years ago), chronic left bundle-branch block with QRS duration of 148 milliseconds and New York Heart Association class III heart failure symptoms (historically). She underwent implantation of a Medtronic dual-chamber, biventricular ICD over three years ago. Her right ventricular (RV) and left ventricular (LV) lead thresholds were noted in time to be significantly elevated, requiring high-output pacing. Additionally, her Medtronic Concerto CRT-D reached premature elective replacement interval but does not appear to be part of the recent recall. Her right ventricular lead was Sprint Fidelis, model 6949, and was noted on routine follow up to have decreased sensing, in addition to elevation in thresholds. Her LV lead was in the anterior interventricular branch pacing the anterior septum. She presented for lead revision and new generator placement. There was no injury to the patient.


Device:

Type: System, Thermal Regulating
Manufacturer: Cincinnati Sub zero
Brand: Maxi Therm Lite
Model#: (not provided)
Lot #: 769042
Cat #: 876
Other #: (not provided)

Problem:
Patient using Blanketol III with Maxi-therm Lite blanket. Blanket on top of patient noted to be leaking and saturating patient's gown. Nurse noticed that outer coating of blanket appeared to be coming apart. Blanket was saved.


Device 1:

Type: System, Thermal Regulating
Manufacturer: Arizant Healthcare
Brand: Bear Paws
Model#: 875
Lot #: (not provided)
Cat #: (not provided)
Other #: 110-120vac-50/60 Hz; 4.6A

Device 2:

Type: System, Thermal Regulating
Manufacturer: Arizant Healthcare
Brand: Bear Hugger
Model#: 500 OR
Lot #: (not provided)
Cat #: Ref 50201 Rev H
Other #: (not provided)

Device 3:

Type: Warming Gown
Manufacturer: Arizant Healthcare
Brand: Bear Paws Flex
Model#: 810
Lot #: GU1025
Cat #: Ref 81003
Other #: (not provided)

Problem:
Staff reported several instances of patients having red 'splotches' on anterior skin surfaces when the Bear Paws Flex gown is removed following surgery. Information in this report refers to the latest incident, when it was reported that the gowns were being removed from service pending investigation. Prior instances were not able to be identified and verified.

Details in this case:
Patient used gown in holding area with Bear Paws machine. In OR, switched to Bear Hugger. Temp set on high (std practice). Length of procedure approx 2 1/2 hours. When gown removed at the end of the procedure, red splotchy areas were noted on the patients lower abdomen, left groin and left anterior thigh. The hose was found properly connected to the gown. There were no blisters noted. The areas were painless. They faded after approximately 8 hours without treatment.



CLINICAL CHEMISTRY

Device:

Type: Tray, Lumbar
Manufacturer: Cardinal Health
Brand: Cardinal
Model#: (not provided)
Lot #: L9J201
Cat #: 4301C
Other #: (not provided)

Problem:
In preparation for a lumbar puncture, the staff noticed a hole in the cap of the tube. The tray was set aside and another tray was opened. Also, there was a hole in the cap of this tube as well. Both lumbar puncture trays came from the same lot number.


GASTROENTEROLOGY & UROLOGY

Device:

Type: Hemodialysis Machine, Continuous Renal Replacment Therapy
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model#: (not provided)
Lot #: n/a
Cat #: n/a
Other #: n/a

Problem:
While changing the effluent drainage bag, the computer screen on the Prismaflex CRRT (continuous renal replacement therapy) machine froze, causing a scale malfunction that shut off the blood pump. I was unable to restart the blood pump after attempting to "retest" the scale function several times. The patient lost approximately 200 cc's of blood remaining in the system. This filter had been up and running only 15 hours prior to this.


GENERAL & PLASTIC SURGERY

Device:

Type: Carrier, Skin Graft
Manufacturer: Zimmer
Brand: Dermacarrier Ii
Model#: (not provided)
Lot #: 61036899
Cat #: 00-2195-012-00
Other #: (not provided)

Problem:
The mesh carrier that the skin graft is placed on and then placed through the meshing device caused the graft to be shredded, making it unusable. When looking at carrier it was obvious that the "grid" was not the same as the other carrier in the box. The defective carrier was the last one in the box, nothing to compare it to. The graft was placed on the correct side of the carrier.


Device:

Type: Electrosurgical Unit
Manufacturer: Conmed Electrosurgery
Brand: System 5000
Model#: 60-8005-001
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Device comes from manufacturer with set up option set to "Last Setting". In this mode when device is turned on, all power settings revert to levels of last use. This could be the previous case that day, previous case that week or whenever it was last used. This caused a near miss incident when an operator set the cut mode to one power level, then changed to a blend not noticing that the power level increased appraisable, to a level last used. In the incident investigation it was found that this device had been inspected by Clinical Engineering very recently. The conclusion from Clinical Engineering was that the memorized "Last Setting" in the blend mode was the result of testing max power out during the inspection. The device has an internal option to have at power up, to have all power settings set to zero. This is not a user settable option; it is an internal mechanical setting. Two procedural changes have been adopted:

1. All like devices in house have had the internal option setting to power-up to a zero power level by Clinical Engineering.

2. At the completion of interval testing by Clinical Engineering for all Electrosurgical Units, all power settings will be set to zero before being returned to service.


GENERAL HOSPITAL

Device:

Type: Iv Tubing, Connector, Male
Manufacturer: ICU MEDICAL
Brand: Spiros Closed Male Connector
Model#: REF#CH2000
Lot #: 1717298
Cat #: (not provided)
Other #: (not provided)

Problem:
Doxorubicin 23mg/11.5mL hung at a rate of 20mL over 1hr. Doxorubicin came up in syringe with Spiros attached to end and given via syringe pump. Approximately 20 minutes later, Doxorubicin was noted to be leaking from syringe/Spiros. It had pooled on the pump dripped down on the floor. Nurse touched the pump inadvertently and Doxorubicin dripped on her hand. She washed her hands immediately with soap and water and an injury report was completed. No Doxorubicin had reached the patient. Approximately 4-7mLs of Doxorubicin were lost. Chemo spill kit used per policy and procedure. Equipment wiped down as well. Environmental notified and cleaned area. No injury to patient.


OBSTETRICS/GYNECOLOGY

Device:

Type: Bed, Hospital, Birthing
Manufacturer: Hill-Rom Company, Inc.
Brand: Affinity
Model#: AFFINITY
Lot #: NA
Cat #: NA
Other #: NA

Problem:
Patient's husband was sitting on the bottom half of the labor bed, and the bed broke out from under him and he fell onto the floor.

See device images
Affinity Labor Bed Image

Affinity Labor Bed Bottom Half

Affinity Labor Bed Locking Screw


RADIOLOGY

Device 1:

Type: Imaging Coil, Cardiac, 6Channel, 3t
Manufacturer: Philips Medical Systems
Brand: (not provided)
Model#: 43567009711
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Mri, 3t
Manufacturer: Philips Medical Systems
Brand: Achieva 3t
Model#: Release 2.6.3.4
Lot #: (not provided)
Cat #: (not provided)
Other #: Site ID# 505048

Problem:
Patient was getting an MRI scan involving her pelvis when patient complained of a burning sensation on her left side. The patient squeezed the emergency ball and two technologists went in to investigate. The patient had redness to the skin and the apparatus used in the procedure was quite warm. On site personnel from Philips were called as well as our on physicist was notified.

The coil in use when the patient complained of heat was the 6 channel cardiac coil for the clinical 3T scanner. This coil was immediately removed by the techs for the completion of the scan. The Philips service engineer and I inspected the coil. There was visible wear at one of rf balun components. The service engineer removed the plastic covering of this balun to reveal that the solder around ground shield sleeve was mechanically broken essentially around the entire circumference of the sleeve. I speculate the high impedance path to ground at this failure point was the source of heating felt by the patient. The coil was removed from service for repair/replacement by Philips.


Device:

Type: Mri, 1. 5t
Manufacturer: GE Medical Systems, LLC
Brand: (not provided)
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was in MRI for cervical spine MRI. During test she informed the tech that she felt a burning sensation on her right forearm. She was removed from the MRI and the tech looked at her arm. There was no indication that there was anything wrong. The patient's arms were covered, and they completed the test. She contacted the department two days later, stating that she had a blister on her right forearm. She was examined by the Radiology Resident on that date.

It is believed that the patient's skin may have been in contact with the inside of the MRI device without padding or protection.


Device:

Type: Ultrasound Unit, Diagnostic
Manufacturer: Sonosite
Brand: Micromaxx
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was set to undergo an emergency C-section. Physician requested confirmation of fetal heart tones prior to start of the procedure. Ultrasound was ordered. While doing this test the machine alarmed with an error message. The message said, "Error" and nothing more. The physician was not able to obtain the readings that were needed. Patient at 24 weeks with twins. One twin was a live birth; second twin with fetal demise. There is no evidence linking the death of the twin to the equipment failure.

Equipment was removed from patient and BioMed was alerted. BioMed came and sequestered the device. Call placed to manufacturer who explained that they did not know what the "Error" message meant. Manufacturer is requesting that the device be returned to them for evaluation. Risk Management is requesting that device be held at hospital until more details are available.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Events With Physiological Monitoring Systems with Software Issues

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The four primary groups of devices that are in this report are described as:

*Physiological monitors intended for multiparameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits; timed or alarm recordings will be produced (1).

*Physiologic/hemodynamic monitoring and information gathering systems that facilitate clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories (1).

*Central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms (1).

*A module is a modular removable unit that, when used in conjunction with a mating physiological monitor provides the capability to acquire various common physiologic data in a clinical setting (1).

Device descriptions may be referenced at the FDA website for 510K Premarket Notifications

Over the past 2 years, MedSun has received 17 adverse event reports associated with devices manufactured by Draeger Medical Systems, Philips Medical/WITT Biomedical, GE Healthcare, Philips Medical, and Spacelabs Healthcare. The reports were submitted by 12 hospitals between February, 2008 and January, 2010.

The reported device problems were:

5 - Device Rebooted/reset on its own (when it should not have)
4 - Clinical data loss/miscalculation
3 – Communication problems between systems
3 - Screen/display blanking
1 - Software updates (sites did not know upgrade was available)
1 - Human factors

No reports involved a patient death. The potential for patient harm was listed in 16 of these reports. The potential patient outcomes:

9 - Prolonged patient care
4 - Possibility of delayed patient treatment
3 - Possibility of misdiagnosis

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years, and 5 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 5 reports involved female patients, and a total of 1 report involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. FDA follow up with the manufacturer resulted in software updates to systems and devices.

The following table lists the MedSun reports that are described in the device problem summary above.

Events With Physiological Monitoring Systems with Software Issues
ManufacturerDevice Identifiers Description
Draeger Medical Systems, Inc. Infinity Kappa XLT (Report 1)
After the running 15-30 minutes, the monitor powered off and restarted automatically after 30-60 seconds without intervention by the anesthesiologist. Manufacturer response (as per reporter) The manufacturer replaced four of the monitors and reportedly confirmed one as a hardware failure, two units as inconclusive and one report remains outstanding. The stability of the software was in question.
Draeger Medical Systems, Inc. Infinity Kappa XLT (Report 2)
After the running 15-30 minutes, the monitor powered off and restarted automatically after 30-60 seconds without intervention by the anesthesiologist. Manufacturer response (as per reporter) The manufacturer replaced four of the monitors and reportedly confirmed that one as a hardware failure, two units as inconclusive and one report remains outstanding. The stability of the software was in question.
Draeger Medical Systems, Inc. Infinity Kappa XLT (Report 3)
After the running 15-30 minutes, the monitor powered off and restarted automatically after 30-60 seconds without intervention by the anesthesiologist. Manufacturer response (as per reporter) The manufacturer replaced four of the monitors and reportedly confirmed one as hardware failure, two units as inconclusive and one report remains outstanding. The stability of the software was in question.
Draeger Medical Systems, Inc. Infinity Kappa XLT (Report 4)
After the running 15-30 minutes, the monitor powered off and restarted automatically after 30-60 seconds without intervention by the anesthesiologist. Manufacturer response (as per reporter) The manufacturer replaced six of the monitors and reportedly was unable to identify the problem. The stability of the software was in question.
WITT Biomedical Subsidiary of Philips Medical Systems Xper Xper Hemodynamic Cath System, Information Management (IM) upgraded to 1.3.1 on November 3. On November 4, the Xper crashed in the morning during cases/ couldn't chart. Message was "Net Failure".
GE Healthcare Solar 8000M
Tram T451M
I was called to the CICU yesterday afternoon regarding a concern related to an entry on a patient's full disclosure report obtained from a patient's cardiac monitor. It was noted on the disclosure report @ 22:20:59 there was a second tracing of asystole. However, the monitor did not note or record an alarm at that time. The patient's record notes she was transferred to the CICU earlier @ 2100, alert and oriented with a heart rate of 30's; treated with a Dopamine gtt and fluids. Her medical record does not note this 10 second episode, nor does it demonstrate any change in her status (no injury) with this occurrence. On assessment, the patient remains alert and the monitor functioning without incident. Monitor tech (nurse) put in place yesterday to facilitate close visual watch over central monitoring; nurse monitor tech) was released this morning after both patient's bedside monitor and Tram module were replaced for further review.
Philips Medical Systems IntelliVue IntelliVue During patient telemetry EKG/Arrhythmia monitoring, the transmitter battery got weak and died (stopped functioning). The central station was configured to alert the nursing staff through a secondary alarm messaging system to a RF wireless phone system when the battery became weak, and again when the battery needed to be replaced. The "battery weak" alert was transmitted to the nurse by way of the RF wireless phone, the "replace battery" alert was not sent to the nurse. Manufacturer response (as per reporter) A manufacturer's representative has examined the system and observed the problem. It was indicated that further tests needed to be performed at the factory to determine the cause of the problem. It was determined that the weak battery message was sent to the secondary alarm system, but the replace battery alarm was not sent.
GE Healthcare Solar 9500 Patient was induced and shortly after the sternotomy a "lead fail message" was displayed on the monitor as one of the ECG leads (lead V) disappeared. The monitor was adjusted to display two of the limb leads (lead II & lead III) instead. All of the ECG leads and electrodes had been carefully placed and covered, so it was considered unlikely that a pad (electrode) had come loose. The cable connection near the patient was also checked. The CVP pressure tracing at the same time was noted to exhibit significant noise artifact and this did not improve after replacing the pressure cable. A few minutes later, it was observed that the arterial line tracing would disappear suddenly from the screen without anyone disturbing or changing anything. Then the arterial line tracing would reappear. This did not improve after changing the pressure cable several times and changing the transducer, so it was assumed that the problem was with the physiologic monitor. In view of the fact that the monitor was critical to the surgical procedure, it was opted to use a transport monitor to display the patient's physiologic information. It was determined that the memory in the monitor needed to be rebooted to clear this issue.
GE Healthcare S/5 Extension Module Intraoperatively, some of the remote monitors were noted to be blank in the OR. The monitors came back online spontaneously and then MD was able to reproduce problem by flexing cable on the Extension Rack Module with BioMed in room. BioMed Assessment: Replaced and tested with a new module. Removed the defective module from inventory. The module was suspect to having a software issue.
GE Healthcare Carescape, PDM Five previous Medsun reports were filed last year. Resolution from GE is still pending. Over fifty PDM, Carescape modules are sitting in a box in storage, which have not been deployed to clinical use since receiving them. Unable to obtain the update or definite time line to when the problems will be resolved. The previous Medsun reports filed were for: 1) NIBP Hardware failure with PDM 2) NIBP Issues with PDM and Tram 3) Rebooting issues in PDM 4) SpO2 issues with PDM 5) Temp Issues with PDM. Manufacturer response: Released software upgrade for Solar 8000i. Upgraded monitors at the hospital. Put PDM's (Carescape module) back into clinical use into a small pod of the OR's as a pilot. PDM's experienced the same failures as mentioned in the MedSun reports filed. Pulled devices out of use. Alerted GE. Solution still the hospital is pending a response from GE, with no update or timeline since. The PDM's have been out of clinical use for ~ 1 year at this time.
Spacelabs Healthcare Inc Command Module, 90496 Spacelabs solution was to add an additional server but this still did not work. There are two fundamental things deficient with this system; 1. We have no active monitoring system that detects when the 72-hour disclosure interface is not sending info to the database. The only way staff knows the system is down is when they need to review cardiac rhythms or vital signs and the screen is blank. 2. The current system configuration saves information in a Flash Type memory, when the interface/server is restarted all the information is purged and gone forever. The Spacelabs system needs to write to a permanent archive (hard-drive) that can be accessed after the system is rebooted and restored; the flash memory does not save the tracings when it is restarted. I don't know how this patient critical system can be deficient in both these areas and still be FDA approved? Manufacturer response: It was our IT dept's responsibility to come up with a solution to monitor the interface.
WITT Biomedical Subsidiary of Philips Medical Systems Xper (Report 1)
This is one of three systems having the same issue. The hemodynamic monitoring system has a known software problem that causes the machine to return to pre-edited measurements after a few minutes. Staff need to make notes on print outs and dictate correct results. Philips updated the software in September to: 1.1.1.1291 and again in January 2009 to version 1.2.1474 to resolve the latest issue.
WITT Biomedical Subsidiary of Philips Medical Systems Xper (Report 2)
This is one of three systems having the same issue. The system samples invasive hemodynamic pressures, upon review of a sampled pressure measurement, the technologist edited the measurements. After a few minutes, the system changed the edited pressures back to the pre-edited measurements. The system doesn't print out accurate information. Staff has to make notes and dictate the actual results. Company has stated that it is a known software problem. Philips updated the software in September to: 1.1.1.1291 and again in January 2009 to version 1.2.1474 to resolve the latest issue. Manufacturer response: This system performance issue is a potential patient safety issue. Philips has escalated our issues through their system and has agreed to an on sight meeting on in January to develop a plan of action to address these problems.
WITT Biomedical Subsidiary of Philips Medical Systems Xper (Report 3)
This is one of three systems having the same issue. The system samples invasive hemodynamic pressures, upon review of a sampled pressure measurement, the technologist edited the measurements. After a few minutes, the system changed the edited pressures back to the pre-edited measurements. The system doesn't print out accurate information. Staff has to make notes and dictate the actual results. Company has stated that it is a known software problem. Philips updated the software in September to: 1.1.1.1291 and again in January 2009 to version 1.2.1474 to resolve the latest issue. Manufacturer response: This system performance issue is a potential patient safety issue. Philips has escalated our issues through their system and has agreed to an on sight meeting on in January to develop a plan of action to address these problems.
GE Medical Systems Information Technologies and Cerner Corporation Dash, Solar, Millennium Nurses are currently manually entering vital signs data into the electronic medical record (EMR). Nurses have noticed that the mean pressure value that is calculated by the EMR is sometimes different from the mean value displayed on the patient monitor. A few sample values were obtained: (systolic/diastolic mean) 129/65 81 EMR mean 86; 146/78 95 EMR 101; 134/54 81 EMR 84; 150/98 116 EMR 115. We were unable to verify if this occurs with a different patient monitoring vendor (such as in the ER) because in that case the EMR does not display the mean value. Nurses reporting this problem say that they have seen much larger variations but I do not have specific numbers to report yet. Manufacturer response: Per clinical support with GE, the mean pressure is measured in the oscillometric method and is the most accurate pressure value since the systolic and diastolic are then calculated from the mean. Most EMR's take the systolic and diastolic numbers and then calculate the mean using a formula intended for auscultatory readings. Therefore there will be variations.
Philips Medical Systems IntelliVue Telemetry Unit reported that there were issues associated with a Philips monitor displaying a discharged patient's rhythm and other Protected Health Information (PHI) showing up on a newly admitted patient's rhythm and PHI. Risk Management spoke with a Philips Customer Service Rep. who had already been contacted by our facility Biomedical Dept. about it, and the monitor was sent to their corporate office for analysis and for a report to be provided.
A Philips Field Service Engineer (FSE) came on-site to the facility to download the monitor equipment's history for evaluation and complete a performance testing on the device. Two months after the event a Philips Healthcare Informatics/Pt Monitoring Quality & Regulatory Specialist provided a report specifying that on the date of the report a newly admitted patient had an alarm occur and staff noted an alarm strip with a similar rhythm was in this new patient's alarm history, but the strip had an earlier date on it which was prior to the admission date of the second patient. The report said they had investigated the issue and determined there was insufficient information provided to confirm that any device malfunction occurred. The FSE verified the device was performing according to specifications and was alarming and storing/recording alarm strips appropriately. The FSE collected and analyzed log files but a complete analysis could not be performed due to the prior patient's admission and discharge had not been provided. The Logs did show the last discharge/remove data action performed for a patient prior to the incident two days prior to the incident @ 16:22. In some cases, a patient may be discharged from the central but may remain on their monitoring device for short time and may continue to generate alarms which will then be stored for that bed. If another discharge is not performed before a new patient is admitted, this prior alarm data will be appended to any new patient admitted to the bed. Philips indicated information about admitting/discharging could be found in the IntelliVue Information Center Instructions for Use, Part # M3150-9001J, in the Section on Patient Management. Philips HC indicated they would continue to review and monitor internal quality records associated with the involved product and would take appropriate actions as necessary.
GE Medical Systems Information Technologies Dash 4000 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.


Additional Information:

1. "510(k) Premarket Notification". U.S. Department of Heath and Human Services, Food and Drug Administration.
http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPMN/pmn.cfm

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Updated April 1, 2010

Return to MedSun: Medical Product Safety Network

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