There was no known patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).Review of the dhr did not identify any deviations or nonconformities relevant to the issue.The affected device was sent to the manufacturer site for investigation.Results confirmed the reported issue and traced it back to a defective component on the motor control board.The part was replaced, and the issue solved.Subsequent functional verification testing was completed without further issues, and the unit was returned to service.
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