Model Number 16-02-80 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Both patient pumps and the distribution board were replaced to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 heater-cooler system 3t displayed error messages during priming.There was no patient involvement.
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Manufacturer Narrative
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H.10: the most likely root cause of the reported errors is traceable to defective pumps circuit boards which led to damage of the safety resistors on the distribution board.
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Event Description
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See initial report.
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Search Alerts/Recalls
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