Two More Deaths Linked to Intra-aortic Balloon Pumps
The US Food and Drug Administration (FDA) said Tuesday that since notifying physicians of particular intra-aortic balloon pump (IABP) device failures last November, two more patients have died and one more serious injury has occurred.FDA in July designated Getinge’s Maquet/Datascope recall of its Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i IABPs as Class I after five patient deaths were reported since 2016.
“Although the deaths cannot be definitively attributed to the device shutting down, these devices are used on critically-ill patients in health care facilities, including during transport, and any interruption in treatment can result in serious patient harm or death,” FDA said Tuesday, noting that it’s still trying to ascertain why the devices are shutting down while running on battery power.
FDA recommends facilities that continue to use the devices review the Getinge notice, which calls on users to ensure the IABP is plugged into an AC power outlet “whenever possible during patient use to prevent the battery from depleting.” And even when not in use, the company says to ensure the IABP is plugged into an outlet to keep the batteries at a full charge.
“Although the FDA remains concerned about the device shutdown events associated with Maquet/Datascope IABPs, we recognize that these systems may be the best option for circulatory support for some patients,” the agency said.
Getinge Group subsidiary Datascope received a warning letter from FDA last February related to issues with its Cardiosave IABP, as well as issues with device design validation, establishing procedures for corrective and preventive actions (CAPAs) and evaluating and selecting potential suppliers. Datascope also received a warning letter in October 2018.
Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers