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: 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).The lab report confirming the reported contamination has been provided to livanova.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Through follow-up communication livanova learned that the device was regularly cleaned per the instruction for use and that it was placed inside the operating theatre during use at an estimated distance from the surgery field of 2 meters with the fan directed opposite to the patient.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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