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 10/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in blackpool, united kingdom.There was a leakage current in the unit, measured by hospital engineers department: reading 4,600 ua,when the limit is 500 ua.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.This report was due on november 22, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t, after it was turned on, caused a short circuit.In detail, the breaker of the specific socket where the 3t system was plugged in tripped.Mains supply was re-set and the same issue occurred.There was no patient involvement.
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Manufacturer Narrative
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Complaints database analysis revealed that no similar event on this device occurred since its installation in 2018.The reported event is a known issue.Based on findings, a potential breach of the cooling coil can be generated due to stirrer flow in the tank.Consequently, the water will enter the cooling circuit and the compressor unit.This potential failure mode will cause immediate damage of the cooling compressor system.The compressor failure leads to an increase of the leakage current of the device and the circuit breaker will trip.The erosion kit upgrade was already installed on the device in 2019 and includes the new design of the pump head of the stirrer motor to prevent a water flow directed to a narrow area of the evaporator coil.The issue was claimed about more than 4 years after the upgrade which suggests that the issue is most probably caused by the corrosion and not erosion and occurred overtime independently from the upgrade.
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