Model Number 60-02-50 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/19/2019 |
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 system with tubing clamp.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 control panel.The technician replaced the panel to resolve the reported malfunction.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The panel was requested back to livanova (b)(4) for further investigation.A review of the all 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 the speed control knob of a centrifugal pump system with tubing clamp was stucked during procedure.There was no report of patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the reported condition could be reproduced during the investigation at the manufacturer site, it was not possible to control the flow by using the knob.The issue was caused by a stuck shaft angle encoder.Corrective actions are in progress for this issue.
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Search Alerts/Recalls
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