Model Number 60-02-15 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 flow probe did not work during procedure.There was no report of patient injury.
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Manufacturer Narrative
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Further evaluation revealed that the reported issue is a duplicate of mw 9611109-2018-00223.Therefore this complaint was voided and every necessary information can be found in mw 9611109-2018-00223.
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Search Alerts/Recalls
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