Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).The actual sample was received for evaluation.Visual inspection revealed that the sampling line tube had fractured at the joint with the sampling line port on the reservoir.It was also found that the oxygenator module had come off the support arm.Magnifying and electron microscopic inspections of each fracture cross- section of the tube confirmed there was not any anomaly on the surface that could have been a trigger of the generation of the fracture with no embedded foreign substance or entrainment of air bubbles in the tube material.The surface was in the smooth state on some part and in the rough state on 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.Review of the temperatures in (b)(6) from (b)(6) 2018 when the actual sample was manufactured to (b)(6) 2019 when this complaint occurred found that the lowest temperature went down below zero in some months.Reproductive testing was performed based off of this information.Multiple product test samples, after having been cooled down to minus 10 oc, were dropped from 1.5m high in the state of packed in the box in the normal manner.As the result, the tubes of some of the samples became fractured.Review of device history record and product release decision control sheet of the involved product/lot# combination was conducted with no findings.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 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 subjected 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.(b)(4).
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