Model Number 60-02-15 |
Device Problem
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 07/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.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 device and could confirm the issue.He addressed the failure back to a defective shaft angle encoder.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.
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Event Description
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Livanova (b)(4) received a report that the knob for the pump speed control on a centrifugal pump system with tubing clamp was stuck during procedure.There was no report of patient injury.
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Manufacturer Narrative
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H.10: the complained encoder has been requested by livanova deutschand for further investigation.Deviation could be reproduced during the investigation.The shaft encoder was stuck.The most probable root cause for the stuck control panel knob was identified as abrasion/surface damage present on both the shaft and the bushing.
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Event Description
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See initial report.
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Search Alerts/Recalls
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