The user facility reported that when unpacking oxygenator from the plastic bag, a doctor identified the disconnected purge line at the place of its connection with oxygenator body.There were no signs of external package damage or impact on the box during transportation.The damage was detected during unpacking oxygenator from the transparent package.There were no signs of impact on the external or internal package, and also the unpacking was done carefully (occasional or intentional damage is excluded).The procedure outcome was not reported and there was no patient involved.
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D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: address: (b)(6).E3: occupation: perfusionist.1.Record review: 1.1 confirmation of the provided image: it was found that the purge line of oxygenator was fractured from the port.1.2 past experience: we have experienced that the similar fracture may have been occurred when momentary external force was applied while the product was cold.The local temperature from the serial number of actual product (may, 2023) to the date of occurrence ((b)(6) 2024) was investigated.It was found that the minimum temperature was below zero.1.3 the manufacturing record and the shipping inspection record of the actual sample no anomaly was found.1.4 past complaint file: no other similar report of the product with the involved product code/lot# was found.1.5 manufacturing date: may 8, 2023.2.Cause of occurrence/conclusion: based on the investigation result, no anomaly was found in the manufacturing records of actual product.As a possible cause of occurrence, based on our past experience, it was inferred that after the product was shipped from the factory, during the distribution process in the cold season, momentary force was applied to the product while it was cooled, causing it to fracture.However, since the condition of damage on the actual product could not be confirmed, it was not possible to identify the cause of this case.Relevant ifu reference: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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