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 06/17/2022 |
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, 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 duisburg, germany.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 deutschland received a report that when a heater-cooler system 3t is turned on, the fi circuit breaker is triggered.There was no patient injury.
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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: livanova field service technician dispatched to the facility confirmed the issue and traced it back to a defective compressor; pictures of corrosion on the cooling coils have been provided.The unit was removed from service.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 october 2019 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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