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 new castle upon tyne, united kingdom.The most likely cause of the reported issue is cooling coil degradation leading water entering refrigeration cycle and damaging the compressor and to refrigerant leak causing the reported bubbling sound.The customer requested quote/estimate for device repair.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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