Nov 19, 2019: USFDA provides an update on failure related to Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices (Cardiosave Hybrid and Cardiosave Rescue).
From the previous letter to health care providers, the FDA informed providers about the devices shutting down while running on battery power, leading to pump stop and loss of hemodynamic support.
FDA has received over 60 additional medical device reports related to this issue, including two patient deaths and one serious patient injury after the previous communication on November 1, 2018.
The FDA continues to work with the manufacturer to inspect and deal with the root cause of these IABP devices shutting down while running on battery power. At present Maquet/Datascope is developing a Cardiosave battery maintenance software upgrade. https://www.fda.gov/medical-devices/letters-health-care-providers/update-device-failure-associated-getinges-maquetdatascope-intra-aortic-balloon-pumps-letter-health