Model Number 10-80-00 |
Device Problems
Pumping Stopped (1503); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 an oxidized motor control board.The technician replaced the board to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A serial readout was sent to livanova (b)(4) for further 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 s5 roller pump stopped and displayed an error message during procedure.There was no report of patient injury.
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Event Description
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See initial.
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Manufacturer Narrative
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The defective motor control board was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be confirmed.It was found that the reported malfunction was caused by oxidized components one the boards.Fluid ingress is then being determined as the root cause for the reported issue.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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Search Alerts/Recalls
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