Model Number 16-02-85 |
Device Problems
Pumping Problem (3016); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/03/2020 |
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).Livanova initiated an investigation.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 two error messages associated to the patient pump during procedure.In addition another error code was displayed and a stirrer motor malfunction can't be excluded.There was no patient involvement.
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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:a livanova field service representative was dispatched to the facility to investigate and could confirm the reported issue.The patient bridge as well as circuit boards were replaced to solve the problem.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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Search Alerts/Recalls
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