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 patient received a surgery twice in (b)(6) 2016 and not in (b)(6).Two heater-cooler were used during this time but the customer does not know which heater-cooler system 3t was used during the surgery.The customer reported that the devices were cleaned according to the instruction for use (ifu) and placed inside the operation room.However no further testing was performed on the devices and the devices were taken out of use.No other patient infection was reported to the hospital.Device not returned.
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