The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. Previously, the FDA informed healthcare providers in a letter about reports of Maquet/Datascope IABP devices shutting down while running on battery power, leading to pump stop and loss of hemodynamic support.
Since the previous communication on Nov. 1, 2018, the FDA has received over 60 additional medical device reports related to this issue, including two patient deaths and one serious patient injury. Although the deaths cannot be definitively attributed to the device shutting down, these devices are used on critically-ill patients in healthcare facilities, including during transport, and any interruption in treatment can result in serious patient harm or death.
In July 2019, the FDA issued a notification about a Class I recall for all Maquet/Datascope Intra-Aortic Balloon Pumps (IABPs) due to the potential risk of battery failure. As part of the recall, Maquet/Datascope is contacting each customer to schedule a training visit to review updated battery instructions, use, care and maintenance. Additionally, a reference guide specific to each IABP based on the Operating Instructions Manual(s) is now provided with each device.
The FDA continues to work with the manufacturer to examine and address the root cause of these IABP devices shutting down while running on battery power. Maquet/Datascope is currently developing a Cardiosave battery maintenance software upgrade. A similar software upgrade was released for the CS300 and CS100/CS100i in 2017.
