Model Number 10-80-00 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.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 not able to confirm the reported issue.Therefore the device was requested back 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 occlusion mechanism of a s5 roller pump was slipping during procedure.There was no report of patient injury.
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Manufacturer Narrative
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The reported s5 roller pump was returned to livanova deutschland for further investigation.During the evaluation the reported issue could not be confirmed.The device worked according the specification.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.As the issue could not be reproduced or confirmed, a root cause was not identified.
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Event Description
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See initial.
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Search Alerts/Recalls
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