The US Food and Drug Administration (FDA), is updating healthcare providers about device failures caused by the intraaortic balloons of Getinge’s Maquet/ pump pumps (IABPs), which comprise the Cardiosave Hybrid and Rescue, CS300 and CS100i devices.
According to an letter published by the FDA The agency found that the Maquet/Datascope cardiosave hybrid and Rescue units might not recognize AC power when plugged into and could shut down abruptly.
The FDA advised providers from November of 2018 that the Maquet/Datascope IABPs could be at risk of shutting down when running on batteries after receiving more than 75 reports of deaths, including five, in the last year. Getinge started a voluntary recall in 2019 to conduct training visits and review battery reference guides with users.
The manufacturer has issued three recalls on a voluntary basis in response to failures of devices with the Rescue IABP and Cardiosave Hybrid devices. They include:
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A class 2 recall warning that Cardiosave IABP units could suddenly stop functioning if they are operating on AC power and have only one battery installed.
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A class 1 recall that certain Cardiosave Li-Ion batteries may have shorter battery life and should be avoided.
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A class I recall issued last week for fluid leaks that may cause unexpected pump shut down or inability to begin therapy.
“The FDA wants to ensure that healthcare professionals and users of Maquet/Datascope Cardiosave IABP devices are aware of the risk of unexpected shutdowns and the manufacturer’s announcements regarding the recent recalls,” the agency said today.
“While the FDA is concerned about device shutdown events that may occur with Maquet/Datascope/IABP devices,” it said.
The FDA’s November 2019 guidance to Maquet/Datascope IABP IABP servicers as well as users of the device are reiterated in the revised notice.
It is urging the manufacturers to report any adverse incidents related to the recalled Device, the Getinge Maquet/Datascope IABP, to the FDA through MedWatch its adverse-event reporting program.
“The FDA continues to work with the manufacturer to study and resolve the root causes of Maquet/Datascope Cardiosave IABP device failures while operating on battery power or AC power and will keep the public informed if any significant new information or recommendations are made available,” the agency said.
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