Abbott (NYSE:ABT) has issued a field safety notice for its HeartMate 3 Left Ventricular Assist System mobile power unit, citing loss of power due to static electricity.
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.
