Implanted date: device was not implanted, explanted date: device was not explanted, occupation - other, pma/510(k)- k071494, k130520.The actual device was not returned for evaluation.Review of he provided image confirmed that the purge line of the oxygenator had been fractured at the connection with the oxygenator port.It is known from our experience that a fracture similar to that observed on the actual sample may occur when the product in a low-temperature condition is subjected to a momentaneous shock load.Based on this, the temperature in the involved site for the past one year from the date of occurrence (b)(6) 2022 was checked and confirmed that the lowest temperature was below freezing.Assuming that the fracture occurred during transportation or storage, multiple test samples packed in unit boxes were cooled, and then dropped from 1.5 meter high.As a result, some of the tubes were fractured at the joint with the product.The test condition was set discretionarily.Review of the manufacturing record and the product-release judgement record of the involved product/lot number combination confirmed there was no indication of anomaly in them.A search of the complaint file found no similar report with the involved product code/lot number combination.Based on the results of the investigation and the description of the complaint that the fracture was found upon opening of the box, it was presumed that the actual sample, which was in a cooled state due to the air temperature during transportation or the storage condition in the cold season, was subjected to a strong shock load when handled, leading to the fracture of the tube.However, since the actual sample was not available for analysis, the definite cause of occurrence could not be determined.Relevant ifu (instructions for use) reference: if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution).(b)(4).
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