HeartWare issues voluntary urgent medical device correction for VAD batteries

2 May 2014 (Last Updated May 2nd, 2014 01:00)

Developer and manufacturer of miniaturised implantable heart pumps or ventricular assist devices (VAD), HeartWare International, has issued a voluntary correction notice about earlier-than-expected battery depletion and routine battery handling in the HeartWare ventricular assist system due to a rise in customer complaints.

hvad

Developer and manufacturer of miniaturised implantable heart pumps or ventricular assist devices (VAD), HeartWare International, has issued a voluntary correction notice about earlier-than-expected battery depletion and routine battery handling in the HeartWare ventricular assist system due to a rise in customer complaints.

The HeartWare ventricular assist system is designed as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

The company is providing information to assist patients and clinicians in monitoring battery performance, recognising abnormal behaviours and reinforcing proper power management.

However, premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death.

In the notice, the company also instructed patients to stop using the battery, if it shows abnormal behavior and contact their VAD Coordinator for a replacement.

"The company is providing information to assist patients and clinicians in monitoring battery performance, recognising abnormal behaviours and reinforcing proper power management."

The company said HeartWare batteries will begin to lose charge over time, similar to the battery in a mobile cell phone.

It also requested patients to replace the affected battery, if a fully charged battery lasts less than two hours or if the controller switches back-and-forth between batteries.

According to the company a total of four deaths were reported to HeartWare, which it says were not directly related to a faulty battery.

Between 1 January 2011 and 31 March 2014, three deaths were reported that were potentially related to power source management.

Of those, two occurred after both sources of power were simultaneously disconnected, a third occurred because of an old battery and the fourth was likely caused by an accidental disconnection of the driveline.

Clinicians and patients are encouraged to review the correction letters and the patient manual to ensure proper power management.


Image: The HeartWare system featuring a HVAD circulatory assist device with a sintered inflow cannula displaces a volume of approximately 50mm. Photo: courtesy of HeartWare International, Inc.