LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 16-02-80 |
Device Problem
Electrical Shorting (2926)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
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 deutschland manufactures the heater-cooler system 3t.The incident occurred in manchester, united kingdom.A refrigerant leak from the cooling coils is suspected which lead water entering cooling circuit damaging the cooling compressor and causing the short circuit.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 received report that a heater cooler 3t tripped the mains circuit once the compressor is activated.There was no report of patient injury.
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Manufacturer Narrative
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H.10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.As anticipated in the initial report, the failure was traced back to a defective compressor.The device will not be repaired and has been scrapped.The reported event is a known issue.Livanova put in place corrective action to reduce this type of events in case of breach of the cooling coil being generated due to stirrer flow in the tank leading to hole formation in a narrow area of the coil.However, in this specific case, the exact location of the hole on the cooling coil could not be determined.In (b)(6) 2021 it was performed the erosion kit upgrade of the device that includes the new design of the pump head of the stirrer motor to prevent the water flow directed to the narrow area of the cooling coil.The reported event was claimed after the upgrade and it is not possible to exclude that the condition of the cooling coil was already compromised before the upgrade to such an extent that the copper was rather degraded.
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Event Description
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See initial report.
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