There was no known patient involvement 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: 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 that is was placed inside the operating theatre during use at an estimated distance of three 83) meters from the surgery field with the fan directed opposite to the patient.Livanova learned that the hospital is user of re-usable blankets which are a potential source of contamination and may have led/contributed to the reported event.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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