Another death has been linked to HeartWare International’s left ventricular assist device (LVAD) heart pump. This is at least the second death and one of at least five dozen incidents involving this medical device.
According to a MassDevice.com report, the female patient died at a local hospital after she was found in her home. The woman allegedly experienced controller alarms in her HeartWare LVAD shortly after she replaced its batteries. The controller fault alarm was followed by a sustained drop in flow and power, according to the adverse event report filed with the U.S. Food and Drug Administration’s MAUDE database.
The incident was reported on Feb. 25 of this year and follows a report logged in the same database in December of last year. There are currently at least 60 adverse event reports linked to HeartWare International’s LVAD device, according to MassDevice.com.
The HeartWare LVAD features an implanted pump, an external driver and a power source that is able to be used both in and out of the hospital setting. HeartWare International recently was granted FDA approval to market this specific device as a “bridge to transplant” for heart failure patients, according to MassDevice.com.