A California medical device manufacturer has issued a voluntary Urgent Medical Device Correction Letter to hospitals who have patients using the company’s HeartMate II left ventricular assist device (LVAD). The Correction Letter advises hospitals to carefully monitor the expiration date of the backup battery contained in the “pocket” system controller that is used with the LVAD.
According to a press release posted on the website of the U.S. Food and Drug Administration (FDA), the company has received a number of reports of patients whose system controllers signaled a low-battery advisory alarm and who then attempted to switch from a primary to backup system controller. In at least three cases, patients were unsuccessful in making the connection to the backup system controller in a timely manner, resulting in two patient deaths and one serious injury.
The Correction Letter advises hospital healthcare professionals to closely monitor the age of system controller backup batteries, and to prioritize replacement of those batteries nearing the 36 month expiration date in order to prevent the occurrence of low-battery advisory alarms.