There was no known patient involvement.The heater-cooler 16-02-82 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 as per the ifu and that it was placed inside the operating theatre during use with the fan directed opposite to the patient and at an estimated distance of 4-5 meters from the surgery field.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|