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Patients' responses to for the HeartMate II left ventricular assist device (LVAD) have led to two deaths and one serious injury, manufacturer Thoratec warned in an alert sent to hospitals and distributed through the FDA's MedWatch system.
The backup battery for the system controller has a 36-month expiration date, with an alarm automatically set for noon on the first day of the month of expiration.
Although the system will continue to function normally after the alarm, "some of these patients who received the advisory alarm attempted to switch from their primary to backup System Controller, and of those, three were unable to connect their pump to their backup System Controller in a timely manner, resulting in two patient deaths and one serious injury," the alert explained.
System controllers with serial numbers starting with the letters "PC" received more than 2 years ago should immediately have the expiration date of the primary and backup batteries checked and the batteries replaced, if necessary. Those received more recently should have the primary and backup batteries checked at each clinical visit.
"As a reminder the backup battery should be replaced approximately 6 months before expiration, dependent upon your clinic schedule," the alert stated.
System controllers with a serial number starting with "EPC" are not affected.
The HeartMate II LVAD had a in 2014 over a similar issue when at least four patients died and five lost consciousness or had other symptoms of hypoperfusion due to difficulties switching from a primary controller to a backup.
The device also faced a class I recall for kinks in the outflow tract in 2012.