Manufacturer's investigation conclusion: incidental findings: pin stuck inside lemo connector of white power cable.The heartmate 3 system controller (serial number: (b)(6)) was returned for evaluation due to a broken pin causing a communication issue with the system monitor.Upon initial observation, a pin was found stuck inside of the lemo connector of the white power cable.The pin appears to have come from a power module patient cable.The pin was removed, and the controller was functionally tested.The controller was connected to a system monitor, power module, and mock loop.A log file was downloaded for review with events spanning approximately 2 days ((b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2021 per timestamp).Events occurring on 13sep2021 were recorded during testing at abbott labs.The log file did not contain any events that would indicate an issue with the controller.The controller passed all testing without any issues or alarms occurring and was able to support the pump for an extended duration of time.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial number: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms.Heartmate iii instructions for use section 8 entitled ¿caring for the equipment¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store 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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