Model Number 16-02-80 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).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 and confirmed the reported issue.The patient pump was found to be blocked thus it was replaced.The issue was 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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Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error code associated to a patient pump during priming.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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H10: the most likely root cause of the reported event is reasonably assigned to environmental conditions in which the pump worked.Indeed, water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase may have caused its failure.
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Search Alerts/Recalls
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