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: k052601).Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The causes that contributed to this issue are related to the age of the device and the leakage of fluid in the compressor.In case of a hole of the evaporator, the refrigerant fluid will leak and water will enter the cooling circuit.This situation will cause a damage of the cooling compressor.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Corrective actions are in progress for this issue.
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