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 not able to confirm the reported issue; the device worked according the specification.Livanova (b)(4) requested the pump back for further investigation however the pump was not made available by the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced or confirmed, a root cause was not identified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|