STORY FROM: Drugs & Medical Devices
FDA Investigating Intra-Aortic Balloon Pumps Shutdowns While Running on Battery Power
November 2, 2018
WASHINGTON, D.C. — The Food and Drug Administration has informed health care providers that it is evaluating recent reports that Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices are shutting down while running on battery power.
In the Nov. 1 letter, the agency explained that since 2017, it has received more than 75 medical device reports of the devices shutting down while running on battery, leading to pump stop and loss of hemodynamic support.
“Five of these reports described three patient deaths, although the deaths cannot be definitively attributed to the device shutting down,” the letter says. “Other reports ...