This report is being submitted as follow up no.1 to provide the completed investigation results.It was initially reported that the actual device was available.It has now been reported that the actual device is no longer available and will not be returned for evaluation.However, a photograph of the actual sample was returned for evaluation.Therefore, the investigation is based on evaluation of the user facility information, the returned photograph and a retention sample from the reported product code/lot number combination.Upon reviewing the photograph, it was found that the sampling line tube that had been fractured.The retention sample was unpacked from the unit box for visual inspection.It was confirmed not to have any anomaly, such as a break.The blood phase was filled with saline solution.With the blood outlet port side clamped, the blood phase was pressurized by applying air of 2kgf/cm2 from the blood inlet port side.It was confirmed that there was no leak.Functional testing was conducted based on review of the temperatures in russia from august, 2017 when the actual sample was manufactured to may, 2018 when this complaint occurred found that the lowest temperature went down below zero in some months.With this information being taken into account, based on the assumption that the actual sample was exposed to some force in the circumstance where the temperature was low, the following reproductive test was performed with the test conditions being set arbitrarily.A test product sample, after having been cooled down to minus 10 degrees celsius, was dropped from 1.5m high in the state of packed in the box in the normal manner.As the result, the tube became fractured.There is no evidence that this event was related to a device defect or malfunction.The investigation verified that the retention sample was the normal product with no break on it.Based on the reproductive test result, it is assumable as a cause of this complaint 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 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.The ifu states: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.".
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