FDA early alerts flag pump controllers, software

Editor's Note

Recent early alerts from the US Food and Drug Administration (FDA), issued when the agency becomes aware of potentially high-risk issues, involve Abiomed’s Automated Impella Controller (AIC) and infusion pump software from Baxter.

The AIC system, which is the user control interface for the Impella catheter blood pump, was reportedly flagged due to the risk of not detecting a connected pump during console-to-console transfer or case start. Risks to patients include inadequate hemodynamic support, which is particularly concerning for those in cardiogenic shock. According to FDA, Abiomed had reported no serious injuries and 3 deaths as of June 13.

Users should have a back-up AIC available in the unlikely event of a device failure. The full FDA announcement offers additional detail, including more specific instructions for case-start and console-to-console failures.

As detailed in the second June 30 FDA safety alert, Baxter’s infusion pump software could be the wrong version for the pump, with versions intended for Spectrum V8 being installed on V6 pumps and vice versa. Risks include as confusion, delay, or mis-programming, furhter resulting in interruption of therapy, underinfusion, or overinfusion. Depending on the patient and the treatment, outcomes include drug toxicity, overdose, fluid overload, electrolyte imbalances, and delayed or subtherapeutic drug levels.

No injuries or deaths had been reported as of June 12. The full FDA announcement offers instructions for identifying and reporting affected devices for service.