The user facility reported that first they did bypass for 75 min.Then the patient was smoothly off after the echo was done.Protemen was given to the patient at that time out all pump suckers was off.After a few minutes, the patient had some problem again, so they gave them heparin and initiated bypass the patient.Second time we found problem in oxygenator and the oxygenation did not occur and they replaced with new one.The procedure was completed successfully.There was no harm to the patient.
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The actual sample was not returned to ashitaka factory, therefore an evaluation of the actual sample could not be performed.The provided photos and video of the actual product were confirmed.Any anomaly such as breakage that could lead to gas transfer failure could not be read from the photos.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.Based on the investigation result, any anomaly such as breakage that could lead to gas transfer failure could not be read from the provided photos, and also no anomaly was found in the manufacturing record.It was described in the reported issue that "the patient smoothly off after done echo and protamine given to the patient.After few minutes, patient got some problem again we gave the heparin and initiate the bypass the patient.Second time we found problem in oxygenator and the oxygenation not occur".Therefore, it was inferred that after neutralizing heparin with protamine, blood clots formed in the oxygenator, leading to gas transfer failure.However, since the actual product could not be confirmed, the cause of occurrence could not be clarified.Ifu states: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings): adequate heparinization of the blood is required to prevent it from clotting in the system.(warnings)." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
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