Patient information not provided.The device serial number has not been provided.This information will be provided in a supplemental report if made available.The heater-cooler 16-02-80 is not distributed in the usa.However, it is similar to the heater-cooler device 16-02-85, which is distributed in the usa.As the device serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the heater-cooler system 3t.The event occurred in (b)(6).Attempts have been made to gather additional information about the patient and the involved device.However, no further information has been provided at this time.It is currently unknown if the heater-cooler device used during the procedure has tested positive for contamination or if there is a definitive link between the device and the reported patient infection.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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