Model Number 60-02-60 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Through follow-up communication livanova learned that the customer may have accidentally powered off the unit during the procedure.Investigation is ongoing to clarify the cause of the reported event.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) monitor went blank during a procedure.Based on information currently available a pump stop cannot be excluded.There was no report of patient injury.
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Manufacturer Narrative
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H.10: the s5 console read-out analysis has been performed and no errors related to any malfunction of the cp5 device were found.Based on functional test and read-out analysis performed, the most likely root cause is an user error accidentally turning off the device.
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Event Description
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See initial report.
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Search Alerts/Recalls
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