The FDA this week posted a letter to healthcare providers warning of reports that Getinge‘s (PINK:GETI B) Datascope and Maquet intra-aortic balloon pumps are shutting down while running on battery power, which could result in serious injury or death.
The company’s intra-aortic balloon pump is designed to be implanted in the descending aorta distal to the left subclavian artery. The system is intended to provide temporary support to the heart’s left ventricle using an electromechanical system to inflate and deflate the balloon, increasing coronary perfusion and reducing left ventricular work, the agency said.
The FDA said that it has received over 75 medical device reports of Maquet and Datascope IABP 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. Other reports describe serious patient injury such as a sudden drop in blood pressure or the need for resuscitation. At least six reports indicated that there was no alarm warning before the device shutdown,” the FDA said in its letter.
The onset of the shutdowns range from immediately after disconnection of the device from AC power to within the expected battery lifespan, the federal watchdog said.
The FDA said that it also received reports describing non-shutdown battery issues, including the battery not charging, battery charge indicators not working and the battery depleting sooner than expected. The agency said that these issues could also lead to unexpected patient harm.
The root cause of the issue is not known, the federal watchdog said.
The FDA said that despite the issues, the devices “may be the best option for circulatory support for some patients,” and added that it was looking to raise awareness of the issue to reduce patient harm.
The agency advised that the devices be plugged into AC outlets whenever possible during patient use, as well as while the system is not in use. It added that users should be careful when transporting the device, and that operators should check battery run time and replace batteries as required.
The FDA suggested that any users experiencing issues should reach out, and that devices with known defects or malfunctions should be returned to the manufacturer.
In June, the FDA labeled a select recall of Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I.