Model Number 60-01-00 |
Device Problems
Thermal Decomposition of Device (1071); Failure to Pump (1502)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier and weight not provided.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 a centrifugal pump system with tubing clamp pump did not start and after increasing the speed smoke came out of the engine during the procedure.There was no report of patient injury.
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Manufacturer Narrative
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The centrifugal pump system was returned to livanova (b)(4) for further investigation.During the evaluation it was found that a electronic component burned out on the board.During the investigation livanova (b)(4) determined that the burned out component was caused by incorrect user handling.
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Search Alerts/Recalls
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