There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.As per equipment maintenance interventions prevention the motor controller board was replaced and the unit was put back in service.It cannot be ruled out that the cause of the reported error message was an intermittent connection between the computer board and the motor controller board.
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