Model Number 60-02-15 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/03/2019 |
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).The defective device was requested back to livanova (b)(4) for further investigation.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.
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Event Description
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Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp encoder became stuck and difficult to rotate during installation.There was no patient involvement.
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Manufacturer Narrative
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Livanova deutschland has sent the defective component to the component manufacturer for further investigation.Upon investigation, the part manufacturer traced the issue back to the use of the same material for the bearing and the shaft itself.As corrective action, new batches of the component will be manufactured with two different materials.
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Search Alerts/Recalls
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