Model Number 10-80-00 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective motor endstage and motor control board.Both boards were replaced to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The boards were requested back to livanova (b)(4) for further investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the 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 s5 roller pump displayed an error message during priming.There was no patient involvement.
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Event Description
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See initial.
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Manufacturer Narrative
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The boards were returned to livanova deutschland for further investigation.During the intense evaluation the reported issue could not be reproduced.The boards worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.
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Search Alerts/Recalls
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