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).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Through follow-up communication livanova learned that this specific device was not in use during covid-19 period and the tanks were drained and left empty for 3 months.Reportedly, the device was subjected to routine cleaning as per the ifu.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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