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 (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to refrigerant leak from the patient side cooling coil and a bubbling sound could be heard.Through follow-up communication livanova learned that the center performed routine disinfection cycle on a weekly basis and this is not in accordance with the instruction for use which prescribes device disinfection every 14 days.The corrosive action of disinfectants may lead to degradation and may resulted in a hole in the cooling coil.The hole in the cooling coil causes refrigerant leak and water entering the refrigeration cycle that damages the cooling compressor.Thus, the increased frequency of disinfection cycles applied by the customer likely exacerbated the above mentioned effect leading to a premature failure of the device.The customer decided to scrap the machine and replacing it with another one.
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