There was no known patient involvement.(heater-cooler special).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).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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Through follow-up communication livanova learned that the device is placed inside the operating theatre during use with the fan opposite to the patient and tat an estimated distance from the surgery field and the device of about 2 meters.Moreover, livanova learned that the device was not cleaned regularly per the instruction for use since a solution with the same recipe of clorox regular beach is used and the water quality monitoring is not performed.In addition, the hospital is user of reusable blankets which likely are a source of contamination.A combination of all the above mentioned deviation led to the reported event.
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