(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of the system error 3 alarm is confirmed.A video was submitted showing the alarm and the field service technician checked the pump, and confirmed burn damage to the m-force assembly.As a result, the m-force assembly was replaced, and the pump was returned to service.A capa investigation determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.
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