There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The issue was traced back to a defective drive unit.The drive unit was replaced and the problem solved.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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