Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump 5.The incident occurred in (b)(6).The defective pump was returned to livanova (b)(4) for further investigation.A serial readout of the pump was performed and records of the reported issue could be identified.However, during the investigation it was not possible to reproduce the reported issue.Several intense testings were performed but the device worked according the specifications without a malfunction.Therefore a specific root cause for the reported issue could not be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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