There was no known 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) 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 learned that the device is cleaned regularly per the instruction for use and that it was placed inside the operation theatre during use with fan directed opposite to the patient and at an estimated distance of two (2) meters from surgery field.The device will be sent to the manufacturer site for deep disinfection in order to solve the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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