Model Number 60-01-00 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
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 system with tubing clamp.The incident occurred in (b)(6).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 (b)(4) received a report that a centrifugal pump system with tubing clamp displayed an error code during procedure.There was no report of patient injury.
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Manufacturer Narrative
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H.10:a livanova field service representative was dispatched to the facility to investigate the device and confirmed the issue.The involved drive unit was replaced with a new one and was then investigated.A defective motor control board was found.The part was replaced and the problem solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Event Description
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See initial report.
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Search Alerts/Recalls
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