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 and maintained as per the instruction for use and that it was placed inside the operating theatre during use at an estimated distance of two (2) meters with the fan pointing away from patient outside central airflow zone of theatre.Furthermore, livanova learned that the tanks are emptied during period of non-use(i.E.Weekends).However, the hospital has one device left full of water for emergencies while the other two devices remain empty.For the emergency unit the peroxide (h2o2) level is not checked on a daily basis as prescribed by the ifu (not checked during weekends).Reportedly, for this specific device the h2o2 level was adequate when checked on monday.Moreover, livanova was informed that the hospital is user of reusable blankets which may have caused/contributed to the reported contamination.
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