Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was returned for evaluation.Visual inspection revealed the sampling line tube had fractured at the joint with the oxygenator sampling port.From this finding, it is most likely that the reported leak occurred at this fracture.There was not any other anomaly, such as a crack, on the remainders of the device.Magnifying and electron microscopic inspections of the fracture cross- sections of the sampling line tube confirmed there was not any anomaly on the surfaces that could have been a trigger of the generation of the fracture with no embedded foreign substance or entrainment of air bubbles in the material.The surface was in the smooth state on some part and in the rough state on the other part.On the smooth part some streaks were found to have been generated.This streak pattern implies that the fracture occurred at one point and developed in the direction of the streak pattern.Reproductive testing was performed.The state of the fracture on the actual sample is experientially known to be consistent with the state when the tube has been damaged as a result of exposure to some shock force under a cold temperature.Review of the temperatures in (b)(6) from july 2018, which is the month when the actual sample was manufactured, to (b)(6) 2018 when this complaint occurred, found that the lowest temperature went down below zero in some months.With this information being taken into account, the reproductive test was performed on a test sample with the test conditions being set arbitrarily.A test product sample, after having been cooled down to minus 10 oc, was dropped from 1.5m high in the state of packed in the box in the normal manner.As the result, the tube got fractured off the port partially.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, including the state of the fracture surfaces of the actual sample and the reproductive test result, it is likely that the actual sample was cooled down due to a low temperature during transportation and/or due to the storage environment and that, in this state, it was exposed to some excessive shock force due to being handled inattentively during transportation or storage, resulting in the reported fracture of the tube.However, the exact cause of the reported event cannot be definitively determined based on the available information.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.(b)(4).
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