Model Number 60-01-04 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in augusta, georgia.Livanova initiated an investigation.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 deutschland received a report that a centrifugal pump 5 (cp5) gave a motor control failure error message during procedure.There was no patient injury.
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Manufacturer Narrative
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H10: a livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Cp5 drive unit was replaced as a precaution.Subsequent functional verification testing was completed without 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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Event Description
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See initial report.
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Search Alerts/Recalls
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