A medical equipment manufacturer is issuing a voluntary device correction for a heart monitor that features potentially misleading information about expiration dates.
Thoratec Corporation has sent a voluntary Urgent Medical Device Correction Letter to hospitals reminding them to monitor the expiration date of the backup battery contained within the HeartMate II "Pocket" System Controller.
The backup battery in question has a 36 month expiration date. If allowed to expire, an advisory alarm, indicated by a yellow wrench symbol, is triggered. This alarm occurs at 12:00 a.m. on the first day of the month in which the backup battery expires.
On Sept. 1, 2015, Thoratec 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 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 Urgent Medical Device Correction Letter is intended to prevent the occurrence of preventable advisory alarms that may result in patients deciding to attempt a battery exchange. Thoratec is working with hospital staff to identify patients that may be close to reaching the 36-month expiration date of their System Controller backup battery in order to facilitate priority replacement and to ensure routine monitoring of backup battery lifetime during clinic visits.
If you are a HeartMate II LVAS patient and the serial number on your System Controller starts with the letters "PC" (i.e. "Pocket Controller") and you received your device more than two years ago, please contact your doctor immediately to have the expiration date of the backup battery within your HeartMate II System Controllers (both primary and backup) checked and, if necessary, replaced.
Thoratec advises that users do not attempt to replace the System Controller unless instructed by your hospital. For all advisory (yellow wrench) alarms, you should first call your hospital contact for instructions.
Patients with questions or who experience this issue should contact their doctor or VAD coordinator at their hospital. Clinicians with questions should contact their Thoratec representative or call Thoratec's customer service line at (800) 456-1477.