Patient information was not provided.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: k052601).Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is (b)(4).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in unknown city.Based on the current level of information, it has not been possible to identify the event and the hospitals where the surgeries took place.If additional information is provided, a follow up report will be filed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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