A.1.-a.5.There was no patient involvement.G.5.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).H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in hasselt, belgium.Livanova initiated an investigation.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, livanova was informed the hospital does not use reusable blankets, the water quality monitoring is applied and the h2o2 checked every day as prescribed by the ifu, the device is used almost everyday except the weekend, device is stored full and the h2o2 is checked daily even during days of non-use (i.E.Week-end), h2o2 is added when the water in the tanks is changed (each 7 days), a disposable pall-aquasafe water filter with an 0.2 m membrane is used for tap water or equivalent performance filter, prior to initial operation and prior to storing the heater-cooler, the surfaces and water circuits are disinfected, device surfaces are not disinfected after every operation and are disinfected once a week (this is not in line with product ifu), the 3t aerosol collection set is replaced after the allowed use period, the device is placed outside of the operation theatre during use.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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