Manufacturer's investigation conclusion: the reported event associated with a communication issue between the controller and the power module/system monitor was confirmed.System controller, serial (b)(4) was returned and intermittently communicated with the system monitor.A current leakage test was performed and the orange wire in the white cable failed.The cable jacket and shielding of the white power cable was stripped revealing a severed orange transmission wire.No other damage was observed.The power cable was replaced to continue testing; the controller was able to support pump function for an extended period of time.The communication issue between the system controller and system monitor was determined to be caused by breakdown of the data transmission wire of the white power cable; however, the root cause of the wire breaking could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial number (b)(4)) was manufactured in accordance with manufacturing and qa specifications.The system controller, (b)(4), was shipped to the customer on 28sep2020.Heartmate 3 instructions for use section 2 entitled ¿system operations¿ and heartmate 3 patient handbook section 2 entitled ¿how your heart pump works¿ states ¿do not twist, kink, or sharply bend the driveline, system controller power cables, or mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.Damage to the driveline or cables could cause the pump to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.Heartmate 3 instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including power cable disconnect alarms.Heartmate 3 instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.The patient handbook cautions the 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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