Model Number 60-02-60 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/15/2019 |
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 5 (cp5).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.
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Event Description
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Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) was reading low flow and no pressure even if the speed was set to 3500 rpms.The device was switched out with another and the case could be completed.There was no report of patient injury.
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Manufacturer Narrative
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A livanova field service representative was dispatched to the facility to investigate and found a broken flow sensor.He replaced the flow probe and the issue could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Event Description
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See initial report.
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Search Alerts/Recalls
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