FDA tacks Class I rating to Getinge recall of a decade’s worth of cardiac balloon pumps

FDA tacks Class I rating to Getinge recall of a decade’s worth of cardiac balloon pumps

Getinge has recalled nearly 8,800 heart devices after receiving more than 100 complaints about them, including one report of a patient death.

The recall—which began in December and came though the Swedish medtech’s Datascope subsidiary—is focused on two models of the Cardiosave intra-aortic balloon pump.

Both the Hybrid and Rescue editions of the device are meant to be inserted into the aorta, where the pumps repeatedly inflate and deflate to help control blood flow from the heart. Intra-aortic balloons are typically used in the first few days of in-hospital recovery after an interventional heart surgery, heart attack or other major cardiac event that can keep the heart from pumping enough blood to the rest of the body.

According to an FDA notice, Getinge began the recall last month after discovering that if a balloon is torn, burst, leaking or otherwise “compromised,” it can cause blood to flow into the pump. If that happens, it could cause the pump to suddenly shut down without advance warning, preventing patients from achieving proper blood flow and therefore potentially causing organ damage or death.

A “blood back event” could also cause patient blood loss or may send helium from the pump into their blood. If gas bubbles form in the veins, creating emboli that block blood flow, they can damage the brain and other organs.

Finally, if a damaged pump is unknowingly used for multiple patients, and previous patients’ blood remains in the pump, cross-contamination could occur. Meanwhile, hospital staff handling the pumps—and even maintenance personnel tasked with fixing them—may also be exposed to patients’ blood if the devices aren’t properly contained.

Getinge received 134 complaints regarding the issue between October 2018 and November of last year. That included 12 reports of the devices completely shutting down and five adverse patient events, comprising four serious injuries and one death.

The recall spans 8,759 balloon pumps distributed around the world, according to the FDA’s database entry, about half of which are in use in the U.S. The affected devices include those distributed as far back as March 2012, all the way through the present date.

As of this week, the FDA has given the recall a Class I rating, the agency’s most serious, denoting a heightened risk of injury or death.

Getinge and Datascope are currently updating the devices’ instructions for use to help users minimize that risk. They’re also considering the possible development of a longer-term design fix that could further address the issue.

In the meantime, clinicians should pay close attention to a handful of alarms that may indicate a perforation in the balloon, and they should also regularly inspect the device’s tubing for evidence of blood flowing into the pump. If any damage is detected, the balloon pump should be removed as quickly as possible and, if needed, replaced.

Share:
error: Content is protected !!