LIVANOVA DEUTSCHLAND HEATER COOLER 3T (230 VOLT); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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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 12/05/2022 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t displayed error messages (error 17&21) associated with pumps using too much power during priming on patient circuits.There is no report of any patient injury.Field service was dispatched to the facilities and confirmed that cardioplegia and both patient 1 pumps were not working.Also distribution board was not working.Pumps, distribution boards, main board, cpu board were substituted.
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Manufacturer Narrative
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Patient identifier: patient information was not provided the heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in australia.Follow with livanova fsa clarified that all three pumps seem to have had contact with water, and the water might have damaged the pump boards.Water came through the top screws holes on the pumps.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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H10: based on the information available, it cannot be ruled out that the reported issue was caused by user error who inadvertently overfilled the unit.
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Event Description
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See initial report.
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Search Alerts/Recalls
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