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 according the instruction for use and that it was used inside the operating theatre during use at an estimated distance of four (4) meters from the surgery field and put at the left of the patient.Reportedly the device water change is performed daily.The device is stored full of water.It is unclear if peroxide level is monitored and if it is added when filling the device as per the ifu.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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