Model Number 10-88-00 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A livanova field service representative investigate the device and could confirm the reported failure.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 s5 mast roller pump gave a motor control failure error message during two operations.Reportedly, the first time it was improved by pump restart.The second time this did not solve the problem which persisted and the device was replaced.There was no report of patient injury.
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Manufacturer Narrative
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H.10: based on previous investigation results, the most likely root cause of the reported event is a defective circuit board.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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