There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).Through follow-up communication with the customer, livanova deutschland learned that the biomed replaced a processor board to fix the issue.The affected part was requested for return to be investigated at livanova deutschland.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Investigation not begun.
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