There was no patient involvement.(b)(6).Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective encoder and processor board.Both components were replaced to resolve the reported issue.Both parts were requested back for further investigation.However both were not made available for further investigation.Therefore no specific root cause could be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.(b)(4) has been resubmitted, since first submission failed due to wrongly stated phone number.
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