The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Backup battery expiration for "Pocket" System Controller used with HeartMate II Left Ventricular Assist System (LVAS), manufactured by Thoratec Corporation. The serial number on the System Controller started with the letters "PC".
The manufacturer issued a voluntary Urgent Medical Device Correction Letter to all hospitals which have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II "Pocket" System Controllers, as specified in the product Instructions for Use (IFU).
According to the manufacturer, this backup battery has a 36 month expiration date; an advisory alarm, indicated by a yellow wrench symbol, is triggered at 12:00 a.m. on the first day of the month in which the backup battery expires. It is important to note that exceeding the backup battery expiration and any associated advisory alarms do not affect normal HeartMate II LVAS function.
While the IFU of HeartMate II LVAS provides information on monitoring and changing the backup battery before it reaches the 36 month expiration date, the manufacturer has recently received reports from several hospitals about a number of patients who encountered an advisory alarm due to the expiration of their System Controller backup batteries. Some of these patients who received the advisory alarm attempted to switch from their primary to backup System Controllers, and of those, three were unable to connect their pumps to their backup System Controllers in a timely manner, resulting in two patient deaths and one serious injury.
The manufacturer is working with hospital staff to identify patients that may be close to reaching the 36-month expiration date of their System Controller backup batteries in order to facilitate priority replacement and to ensure routine monitoring of backup battery lifetime during clinic visits, as specified in the product IFU. The manufacturer also advises the patients who received the affected products with certain serial number and experienced an Advisory alarm should contact their doctors or hospitals for further instructions and do not attempt to replace the System Controllers unless otherwise instructed.
For details, please refer to the FDA website:
http://www.fda.gov/Safety/Recalls/ucm462627.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 September 2015