The FDA has disclosed over 60 additional safety reports relating to intra-aortic balloon pumps manufactured by Maquet and Datascope, including two patient deaths, following a Class I recall this past summer.
The devices, known as IABPs, comprise a long balloon threaded within the aorta, which inflates and deflates as the heart beats to improve blood flow to the body from a weakened heart.
Maquet, which acquired Datascope in 2008, is part of the Swedish medtech company the Getinge Group. The recall included Maquet and Datascope’s Cardiosave pump, in both Hybrid and Rescue models, as well as the CS300, CS100 and CS100i.
In a previous letter to healthcare providers from November 2018, the FDA described reports of these IABPs shutting down while running on battery power, leading to a loss of hemodynamic support.
Since that letter, the agency said it has received over 60 additional reports, including two deaths and one serious patient injury. The FDA said that “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.”
“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 in its notice.
As part of the Class I recall in June and July, Maquet and Datascope have been contacting customers to schedule training visits regarding updated battery instructions, use, care and maintenance, the FDA said. Additionally, the company is developing a battery maintenance software upgrade, similar to releases for the CS300, CS100 and CS100i rolled out in 2017.
The FDA also recommended that operators immediately replace any batteries for the Cardiosave Hybrid and Rescue IABPs that are older than four years, while using batteries approved or sourced by Datascope, and that users should have additional charged batteries on hand during patient transport.
Additionally, the FDA asked the public to report any instances of IABP devices shutting down while running on batteries as a device failure, as the agency works with the manufacturer to address the root cause of the issue.