Patient information was not provided.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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).This medwatch report is being filed on behalf of livanova (b)(4).The customer stated that the cleaning and disinfection procedure has been performed regularly according to the instructions for use (ifu), and that the device was placed inside the operating room during use.The facility plans to return the device to livanova (b)(4) for deep disinfection.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Corrective actions are in progress for this type of issue.Device not returned.
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