Model Number 60-01-00 |
Device Problems
Pumping Stopped (1503); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that the centrifugal pump console displayed an error message and stopped the pump during a procedure.The perfusionist used the hand crank and the pump was replaced.There was no report of patient injury.
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Manufacturer Narrative
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Livanova (b)(4) received the information that the initial provided device information were incorrect.The correct device information are: centrifugal pump system with tubing clamp, 60-01-00, (b)(4).As the device information have changed the manufacturing date was changed.(29.10.2009).Through follow-up communication with the customer livanova (b)(4) learned that the customer discovered some blood clotting in the revolution cone that may have been the cause for the cone stopping.Further the customer reported that he is unsure if the pump has really stopped.However 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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See initial report.
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Manufacturer Narrative
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The device was returned to livanova (b)(4) for further investigation.The device was intensively tested but the reported issue could not be reproduced or confirmed.The device worked according the specification.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 report.
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Search Alerts/Recalls
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