There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected parts were returned to livanova (b)(4) for a detailed investigation.The investigator could reproduce the reported issue.The problem could be traced to mechanical issues.Due to obsolescence of the part a new version of the encoder is used for the manufacturing of the new devices.Corrective actions are in progress for this issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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