There was no known 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 the issue could not be reproduced.The technician identified that the display went off.The issue could be traced back to the processor board.The board was replaced as well as touchscreen components and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Pump serial read-out analysis identified a link interruption between the motor control board and the processor board.Thus, the most likely root cause of the reported error code was an electronic failure of the processor board.
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