The user facility reported that they had an uneventful pump run however, the patient had to go back on bypass to redo repair.Upon going back on bypass, the surgeon stated that the arterial blood looked darker than normal (even though sao2 was 100%, svo2 was 60% and hematocrit was 41%).The f1o2 was set to 95% and drew an arterial blood gas analysis (abg) that reflected a p02 of 271 mmhg.The surgeon felt more comfortable changing out the oxygenator before undergoing the redo, so it was changed out and the po2 afterwards was >600 mmhg.
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This report is being submitted as follow up no.1 to provide the lot number and expiration date in section d4, to provide the device return date in section d9, update section h3, to provide the manufacture date in section h4 and to provide the completed investigation results.H6: investigation findings - 114 is based upon the evaluation of user facility information and the investigation of the returned sample; 213 is based upon functional testing of the returned sample.H6 - investigation conclusion - 4310 is based upon evaluation of the user facility information and the investigation of the returned sample; 67 is based upon functional testing of the returned sample.Review of the manufacturing record and the product release decision control sheet of the actual sample confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.Visual inspection of the actual sample upon receipt did not find any anomaly including a breakage that could lead to gas transfer failure.After rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure manual.It was confirmed to meet the factory's specifications.[bovine blood conditions] hb: 12g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg [circulation conditions] blood flow rate: 2l/min and 1l/min, v/q:1, fio2: 100% [o2 transfer volume] @2l/min: 116ml/min., @1l/min: 66ml/min.[co2 removal volume] @2l/min: 91ml/min., @1l/min: 49ml/min.Based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found in the manufacturing record.In the occurrence situation of this case, there was no information that oxygenation became worse during circulation.Since there was information that 'upon going back on bypass, the surgeon stated that the arterial blood "looked darker than normal", so i set my fio2 to 95%', it was inferred that fio2 was lower than 95% at the start of re-bypass.However, although there was information that "i set my fio2 to 95% and drew an abg that reflected a po2 of 271 mmhg", it was not possible to clarify the color of blood after increased fio2 and the cause of the decision to replace the actual sample.Ifu states: "measure blood gases and make necessary adjustments as follows: a) control pao2 by changing concentration of oxygen in ventilating gas using gas blender.- to decrease pao2, decrease fio2.- to increase pao2, increase fio2.(during perfusion)".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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