Udi: not required for product code.Implanted date: device was not implanted, explanted date: device was not explanted.Pma/ 510(k) - k130520.The actual sample was received for evaluation.Visual inspection upon receipt did not find any anomaly including a breakage in the appearance.The count of blood cells in the blood collected from the actual sample revealed that those of rbc and hb were found low compared to the jccls standards while that of blood platelet was high.Physiological saline solution was flown into the actual sample by gravity and the oxygenation module was inspected visually.No formation of blood clot was found.The inside of the oxygenation module was fixed by being filled with glutaraldehyde-containing saline solution.Then, the housing and the filter were removed and subjected to visual inspection.Formation of blood clots was not found visibly on the outer and inner surfaces of the filter.The oxygenation module was visually inspected.No visible formation of blood clots was confirmed.The fiber layer was removed gradually by 2mm in thickness and the surface of each layer was subjected to visual inspection blood clots were found to have formed on the surfaces.The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections.White clots were found to have formed in the bottom.The filter that had been removed was inspected under magnification.White clots were found to have formed on both the outer and the inner surfaces.No anomaly was observed in the diameter of the filter mesh.The fiber layers removed were inspected under magnification.White clots were found to have formed.Electron microscopic inspection of the filter found blood cell components such as platelets had been adhered to both the inner and outer surfaces.Electron microscopic inspection of the fiber layers found the adhesion of blood cells such as platelets, rbc, and deformed rbc (echinocyte), and formation of fibrin nets.The investigation results showed that white clots had formed in the fiber and the heat exchanger.Electron microscopic inspection of the white clots revealed the adhesion of the blood cell components such as platelets and rbc.From the available information, it was not clarified exactly when the adhesion of the blood cell components occurred.A review of the device history record and shipping inspection record of the involved product code/ lot number combination revealed no findings.Ifu states: adequate heparinization of the blood is required considering patient condition and perfusion technique to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that blood with its platelet agglutination reaction having been activated due to some factors might have flowed into the actual oxygenator, which resulted in the formation of white clots inside the oxygenator.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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The user facility reported that the involved capiox device was used during the procedure.Act before the start of pump was 440 sec.Heparin was added.On starting of pump act was over 800 sec.Not much blood was suctioned; however, high pressure continued.The oxygenator was exchanged with another fx05 of other lot.The procedure was completed successfully.The patient was not harmed.Priming solution: mannitol, ringer acetate, albumin, and map.
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