Manufacturer's investigation conclusion: the reported event of a controller fault condition was confirmed.The provided log file, as well as a log file extracted from the controller, were reviewed.The data collectively spanned approximately 10 hours (05jun2022, 12:40 ¿ 22:44 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.A controller internal fault flag was observed throughout the data correlating to an lcd communication fault flag, indicating that the controller¿s lcd board was not receiving information properly.The returned system controller (serial number (b)(6) was functionally tested, and this fault condition was reproduced.The controller operated a mock loop as intended despite the controller fault.The controller¿s lcd/bitmap software was reuploaded, and further atypical events were unable to be reproduced after this point, indicating that the root cause of the reported event was the controller¿s lcd/bitmap software becoming corrupt.However, the root cause of how the software became corrupt was unable to be conclusively determined.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 patient handbook (rev.D, section 5 ¿alarms and troubleshooting) instructs users on how to resolve alarms that sound from their system controller, including alarms associated with controller fault conditions.The heartmate 3 patient handbook (rev.D, section titled "emergency contact list") cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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