Serial number is unknown.This information will be provided in a supplemental report if made available.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).As the 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 incident occurred in (b)(6).Through follow-up communication with the customer livanova (b)(4) learned that the heater-cooler system 3t was positioned inside the operation theatre approximately 2 meters away from the operation table.In addition, it was reported that the heater-cooler was cleaned according to the instructions for use.The customer does not know which heater-cooler system 3t was used during the procedure.It was possible to confirm the reported patient infection on the replaced valve but the species of the contamination could not be identified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device was not returned.
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