6 Recent Medical Device Failures Catching FDA's Eye

Chris Newmarker

April 18, 2014

8 Min Read
6 Recent Medical Device Failures Catching FDA's Eye

From surgical devices with flaking coating issues to a confusing hook-up for an LVAD backup system controller, there have been six medical device safety issues since mid-March that have drawn attention from the FDA owing to their potential to cause serious injury or death:

1. Covidien Surgical Devices with Flaking Coating Issues

The FDA on Monday announced a Class I designation for Covidien's voluntary recall of two surgical devices used in the area of the brain, both of which have issues involving flaking polytetrafluoroethylene (PTFE) coatings.Surgeons use the the Alligator Retrieval Device is used to remove foreign bodies in the peripheral and neurovasculature, while the Pipeline Embolization Device is in endovascular surgical procedures treating large intracranial aneurysms in the internal carotid artery, from the petrous to the superior hypophyseal segments. FDA officials think the recalled devices could cause stroke or even death because a detached particle of PTFE could cause a blockage (embolism) in blood vessels in the brain. Covidien has had no reports of injuries or deaths, but has received one report of an incident in which the delamination occurred.

Affected products were manufactured and distributed from May 2013 to March 2014. Covidien is asking that unused devices be returned for replacement. PTFE (marketed as Teflon by DuPont) was once the gold standard for coating guidewires and related medical device products, due to its low friction coefficient. But then the EPA required that manufacturers eliminate perfluorooctanoic acid (PFOA) from their PTFE formulations by 2015. The move, meant to answer cancer concerns, also appears to be related to a series of recalls involving flaking coatings, including the Covidien recall.The FDA over the past six months has also announced Class I designations involving coated guidewire recalls at Medtronic and Medline.Suppliers including Surface Solutions Group have been searching for solutions to the issue.

2. Dräger Ventilators with Battery Issues

A Dräger Medical ventilators recall received a Class I designation from the FDA this month.

The company said it has not received any patient injury reports due to the Evita V500 and Babylog VN500 Ventilators, which apparently have optional power supply unit batteries that deplete faster than expected.FDA officials, though, caution that serious injury or even death could result with the issues around the ventilators. Dräger discovered that the battery issue in some cases could cause the ventilators to shut down even though visual indicators showed a sufficient charge, according to the FDA.In some cases, neither the "battery low" nor the "battery depleted" alarm was triggered when the remaining battery capacity was below 10%. Dräger elaborated in its own news release. A power fail alarm, though, did go off when the battery was depleted completely.Battery capacity itself was down due to the occurrence of sulfation within the battery.The batteries were for the optional PS500 power supply units for the ventilators. As an interim solution, Dräger says the batteries in the PS500 will be replaced free of charge.The Evita V500 and Babylog VN500 Ventilators are for adult, child, and infant patients, and are for stationary use in hospitals or for patient transport within hospitals.Affected products were manufactured and distributed from June 1, 2011 through January 31, 2014.

3. Spacelabs Anesthesia Delivery System's Software Glitch

The FDA on April 16 designated a Spacelabs Healthcare recall of an anesthesia delivery system as Class I. The Arkon Anesthesia Delivery System is used in hospital operating rooms. The device is actually a Medical Design Excellence Awards finalist for the way it allows anesthesiologists to keep their patients in full view while simultaneously controlling and monitoring gas delivery using their preferred workflow.Snoqualmie, WA-based Spacelabs in March initiated a voluntary recall of Arkon's with version 2.0 software because the software may cause the system to stop working, requiring manual ventilation of patients and potentially endangering their lives. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.There was also potential for the system to stop working if a mobile phone or other USB device is plugged into one of the device's four USB ports for charging, according to the FDA.Spacelabs Healthcare received a single report related to the software defect. The FDA says there has been no injuries or deaths associated with the software malfunction.The company has field service personnel contacting customers affected by the recall to schedule a free software update installation that may resolve this issue.

4. Abbott Blood Glucose Meters with Test Strip Issues

The FDA this monthly apparently issued another Class I designation involving Abbott Laboratories' voluntary recall of diabetes products. Freestyle test stripsBack in January, the FDA said FreeStyle and FreeStyle Lite test strips could cause serious injury or death because they were found to provide inaccurate readings of blood glucose when used with the FreeStyle and FreeStyle Flash meters and the Insulet OmniPod. (The FreeStyle and FreeStyle Flash devices have not been produced since 2010.) Late last week, an additional Class I designation was announced involving the actual FreeStyle and FreeStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager.The FDA says: "Abbott Diabetes Care has identified that certain meters have the potential to produce erroneously low blood glucose results when used in conjunction with certain Free Style test strips."Abbott has asked users of the FreeStyle and FreeStyle Flash Blood Glucose Meters to discontinue, and to call Abbott for a new unaffected meter. Those using a built-in FreeStyle meter in the OmniPod Personal Diabetes Manager should discontinue use of affected test strips and call Abbott for replacement unaffected test strips.

5. Thoratec LVAD Patients Confused over Controller

The FDA on April 1 issued a Class I recall designation over Thoratec's advisory involving four patient deaths related to its HeartMate II left ventricular assist device (LVAD).

The issue actually has nothing to do with the LVAD itself, but rather is related to patients and caregivers who were unable to understand instructions and lacked the training needed to hook up a back-up system controller in cases of device alarm or malfunction.Besides resulting in four deaths, such difficulties also caused lost consciousness or reduced blood flow for five other patients, according to Pleasanton, CA-based Thoratec and the FDA.The FDA elaborates on what happened:"All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller."Thoratec sent an "Urgent Medical Device Correction" letter by email to all affected customers in early March.The company is updating labeling and training materials for the HeartMate II LVAS Pocket System Controller and has been urging physicians, caregivers and patients to get up to speed on the new instructions and training.Thoratec isn't the only company experiencing potentially deadly issues around device instructions. The FDA has also been warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because it came with inadequate sterilization recommendations.

6. McKesson Anesthesia Care's Patient Data Issues

The FDA last month issued a Class I designation over McKesson Technologies Inc.'s recall of its McKesson Anesthesia Care, a computer-based system used in environments such as operating rooms.An anesthesia provider uses the system to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care. But there was an occurrence where a patient's data in the system included information from another case, the FDA said when announcing the Class I designation on Friday.McKesson Anesthesia Care collects data both through manual entry and from monitors attached to patients.

Alpharetta, GA-based McKesson Technologies Inc., which is part of San Francisco-based McKesson Corp., issued a Clinical Alert in March 2013 over the issue, calling customers on the phone and following up with email.

Previously in March

7 Recent Medical Device Failures Catching FDA's Eye

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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