There was no known patient involvement.(heater-cooler special).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).Through follow up communication, livanova (b)(4) learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operation theatre.The device is placed about 4-5 meters away from the operating field, depending on operation room size and orientation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Corrective actions are in progress for this issue.
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