There was no patient involvement.Livanova (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).The livanova field service representative who discovered the issue replaced the faulty component and subsequent functional verification testing was completed without further issues.The unit was returned to service.The replaced component has been discarded.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.Evaluated on site by livanova rep.
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