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: 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).Within the report it was stated that the unit has been decontaminated and isolated.Tests will be performed by the hospital in order to identify the unknown strain of mycobacterium contaminating the unit.Through follow-up communication livanova (b)(4) learned that the device was cleaned regularly per the instruction for use and that it was placed inside the operating theatre during use.The device was located at an estimated distance of about 8-10 feet (2-3 meters) from the surgery field with the fan away from the patient.A review of the dhr did not identify any deviations or non-conformities relevant to 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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