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 was cleaned regularly per the instruction for use, and was placed inside the operation theatre at an estimated distance of 2-3 meters from the surgery field.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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