The notice identifies power loss to the HeartMate Mobile Power Unit Module due to static electricity. The power unit is connected to the HeartMate 3 Left Ventricular Assist System (LVAS) and the company reports that excessive static electricity could cause unrecoverable power loss and damage to the mobile power unit.
Abbott reports there is currently a 0.2% worldwide complaint rate and there have been two reports of serious injury and no reports of death due to the power loss. The serious injuries were categorized as a hemodynamic compromise.
The company’s field personnel plan to perform training of all sites to reduce excess static electricity. Abbott recommends using battery power instead of the mobile power unit if a patient is not sleeping or resting to power the HeartMate 3 LVAS. If there is an unexpected no external power alarm, patients are advised to connect to battery power to power the HeartMate 3 LVAS.
Abbott also provides recommendations for preventing excessive static electricity. Switching to battery power before folding or changing bedsheets, taking laundry out of a dryer, dragging feet on a carpet, touching screens of older TV or computers can reduce static electricity. The company also recommends using a humidifier, dryer sheets, fabric softener and skin moisturizer to reduce static electricity build-up.
HeartMate 3 LVAS mobile power unit module is the only device affected by the notice. HeartMate II LVAS devices are not affected.