A.1.-a.5.There was no patient involvement.G.5.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).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in manchester, united kingdom.Leakage current was measured by hospital biomedical engineer: 4900 ua, while limit is 500 ua.Livanova initiated an investigation.This report was due on december 03, 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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Livanova deutschland received a report that a heater-cooler system 3t caused a short circuit, after its switching on.In detail, the breaker of the specific socket where the 3t system was plugged in tripped.The device was then switched back on and the issue happened again.There was no patient involvement.
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The livanova service representative in charge was contacted and stated that the heater-cooler 3t was scrapped as it would be uneconomical to repair.A device service history review has been performed and identified that the unit was manufactured in 2017 and no other similar events have been reported.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 (b)(6) 2021 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 year 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.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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