Model Number 60-02-60 |
Device Problems
Loss of Power (1475); Pumping Stopped (1503)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.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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Event Description
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Livanova (b)(6) received a report that a centrifugal pump 5 (cp5) switched off several times and displayed an alarm message during procedure.It was also reported that the pump stopped several times due to this failure.There was no report of patient injury.
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Manufacturer Narrative
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A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective cp5.The device software was upgrade to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Search Alerts/Recalls
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