Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed based on the information recorded in the log file. The data log file was successfully retrieved from the returned system controller serial number (b)(4) and contained events recorded from (b)(6) 2019 where a backup battery fault alarm associated with a battery load test failure was recorded through the entire log file. The pump support was not affected and the system maintained the desired set speed. The system controller was functionally tested using the laboratory equipment and was found to function as intended. A full functional test was performed and the controller passed all test steps. The system controller operated for extended period of time while connected to a mock circulatory loop and the backup battery fault alarm was not able to be reproduced. During testing, multiple load tests were performed and the controller passed each time without issue. A specific root cause of the backup battery load test failure recorded in the log file was unable to be conclusively determined during this investigation. The backup battery fault alarm observed in the log file did not affect the controller's ability to support the pump at the set speed. Abbott is continuing to monitor this issue. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
It was reported that the patient experienced a backup battery fault alarm. Patient's backup battery was replaced, however the alarm returned so the patient's controller was exchanged with no issue. No further information provided.
Patient Sequence No: 1, Text Type: D, B5