FDA Warns of Possible Maquet/Datascope IABP Battery Failure

November 01, 2018

Maquet/Datascope intra-aortic balloon pumps (IABPs) may be at risk of shutting down while running on batteries, failure of their batteries to charge, or premature battery depletion, the US Food and Drug Administration warned clinicians today.

The agency has received "over 75" reports of the devices shutting down while operating on its rechargeable batteries since 2017, the agency said. Five of the reports involved patient deaths, "although the deaths cannot be definitively attributed to the device shutting down."

"Other reports describe serious patient injury such as a sudden drop in blood pressure or the need for resuscitation. At least six reports indicated that there was no alarm warning before the device shutdown."

Without specifying which IABP models were involved, the announcement pointed out that the company manufactures Cardiosave IABP Hybrid and Cardiosave IABP Rescue, and the CS300 and CS100/CS100i IABPs.

Other battery-related issues with a potential for harm have been reported, the FDA said. They include "the device not charging the battery, the battery charge indicator not working properly or not showing the correct status of the battery charge, or the battery depleting sooner than expected."

Whereas the IABP systems may still be "the best option for circulatory support for some patients," the agency said it wants to ensure that clinicians are aware of the device failures and is investigating them.

In the meantime, it provided a list of cautionary measures for their use, such as having the systems plugged in at all times, the batteries fully charged, when they are not in use during patient transport.

November 1, 2018. Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers

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