The serial number has not been provided.This information will be provided in a follow-up report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a follow-up report if made available.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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The serial number was provided: (b)(4).Since the serial number was provided, the device manufacture date could be determined: 08.06.2015.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A review of he device read-out identified no software or hardware failure on the event date.The complete cp5 panel was asked back to livanova (b)(4) for further investigation.Upon device return, no damage was noticed on the external housing, on the internal cables or connectors, or on the pcbs during visual inspection the cp5 panel and the centrifugal pump were connected to the test bench, where they were tested at different speeds.No deviations occurred.The panel was then opened and a read out performed, no deviations were found.Further extensive test have been performed on the hkr board, including thermal preconditioning: no malfunction nor error messages were displayed.The power switch was replaced and a subsequent functional check was performed with no issue.The failure could not be reproduced during the investigation, therefore the root cause is unknown.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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