The system controller and backup battery were not returned for evaluation.The backup battery was reportedly discarded.As the backup battery serial number was not provided, the manufacture date of the backup battery could not be confirmed.Although rechargeable, according to the design, the backup battery has a limited lifespan of 36 months from the manufacture date and a backup battery fault advisory alarm will occur at 12:00am midnight on the first day of the month in which the backup battery reaches its expiration date.The submitted system controller log file contained data from (b)(6) 2016 to (b)(6) 2017 according to the timestamp.On (b)(6) 2016 the system controller was disconnected and powered down.The system controller was reconnected to an lvad and external power on (b)(6) 2017 and supported the pump at the set speed.However, the system controller alarmed with a backup battery fault alarm per design due to the internal backup battery being past its expiration date.This alarm did not affect the system controller's ability to support the pump at the set speed, but remained active until the end of the log file.According to the heartmate ii left ventricular assist system instructions for use, the system monitor displays information about the backup battery charge level and the time remaining before its replacement is mandatory.Depending upon a patient¿s clinic schedule, replacement of the 11 volt lithium-ion battery should be considered when less than 6 months remain before the mandatory expiration date.Reports of backup battery fault advisory alarms occurring for heartmate ii system controllers with backup batteries that have reached their limited lifespan of 36 months have been addressed through the manufacturer''s corrective/preventative action system, updated device labeling for the monthly safety checklist, and an urgent medical device correction notice (2916596-9/14/15-001-c).No further information was provided.The manufacturer is closing its file on this event.
|