There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).The affected device was requested back to the manufacturer site for investigation.The reported issue could not be reproduced, however, the pump serial read-out confirmed the reported error.The most likely root cause of the event is related to an intermittent connection between the computer board and the motor controller board.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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