There was no 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).The device returned from deep disinfection following a previous contamination event reported under medwatch # mw-006424 and # mw-007082.The tests performed at the manufacturer site post deep disinfection resulted to be negative to the m.Chimaera presence.A contamination of the samples at the customer site cannot be excluded.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|