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).It was reported that the device is an emergency device which is usually stored without water.The customer carried out a routine disinfection cycle on (b)(6) 2020, then emptied the tanks.On (b)(6) 2020, the hygiene service took a sample of the water which resulted positive on (b)(6) 2020.It is still not clear if the disinfection cycles were conducted as per the ifu (even during storage, the heater-cooler must be disinfected at intervals of 14 days).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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H10: through follow-up communication under previous case from the same hospital, livanova learned that the device is cleaned regularly according to the instruction for use and that it was placed inside the operation theatre during use with the fan positioned to the wall and at three (3) meter from the surgical field.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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