Manufacturer's investigation conclusion: the reported event of one of the pins in the white power cable connector of the system controller (serial number: (b)(6) breaking off into the battery clip (lot number: 8116514) was confirmed.Visual inspection of the returned system controller revealed that pin 4, which corresponds to a redundant negative power line, was missing from the white power cable connector.Inspection of the returned battery clip revealed that the missing pin from the controller was stuck in the battery clip connector.The system controller successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms produced.The pin stuck in the battery clip was removed and the system controller was also tested with the returned battery clip with no issues observed.The missing pin did not affect the functionality of the system controller as it corresponds to a redundant signal.The log file downloaded from the returned controller contained approximately 3 days of data ((b)(6) 2022 per the timestamp).No atypical alarms were active in the log file.The driveline was disconnected on (b)(6) 2022 to exchange the system controller.The pump maintained a speed above the low speed limit while the driveline was connected.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The system controller, serial number (b)(6), was shipped to the customer on 25jun2021.Heartmate 3 patient handbook (rev.D), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.C), under section 7 ¿alarms and troubleshooting¿ provide guideline for properly connecting and disconnecting the power cable connectors.Heartmate 3 patient handbook (rev.D) section 6 "caring for the equipment" and heartmate 3 ifu (rev.C) section 8 "equipment storage and care" describe how to care for and clean all equipment.Heartmate 3 patient handbook (rev.D) section 10 and heartmate 3 ifu (rev.C) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook (rev.D) section 2 ¿how your heart pump works¿ and heartmate 3 ifu (rev.C), under section 2 ¿system operations¿ explain the system controller user interface, including the display screen and all buttons, lights, and symbols.Heartmate 3 patient handbook (rev.D) 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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