Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A review of the dhr and of the service history records did not identify any deviations or non-conformities relevant to the reported issue.Through follow-up communication with the chief perfusionist livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry.This is not in alignment with current instruction for use however reportedly the devices in use at the hospital are very clean and there is no sign of biofilm.The devices are located inside the operating theatre during use.It is unclear if device serial number (b)(4) (of this specific event) or (b)(4) was found to be contaminated by laboratory test conducted in the middle of 2020.Confirmation of the involved device is still pending to livanova as well as the type of contamination.However, the lab tests were conducted in the middle of 2020 thus, the status of device at the time of surgery ((b)(6) 2019) remains unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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