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 that it was placed inside the operating theatre during use at an estimated distance of two (2) meters from the surgery field with the fan directed away from the patient.The device will undergo deep disinfection in order to solve the reported contamination.No additional information is available on this specific case and root cause could not be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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