This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual and magnifying inspections of the actual sample found a crack was found in the connecting part between the female connector and tubing on the sampling line connected to the oxygenator blood outlet port.The surface of female connector had some marks, and the female connector was also found to have cracks.Leak test of the actual sample found the colored saline solution was flowed into the actual sample by a head.As a result, leakage was found from the crack.X-ray fluoroscopic inspection of the actual female connector found that the tube inside the female connector was also found to have cracks.Simulation test: an impact load was applied to the female connector of current product.As a result, it was found that a crack similar to the actual sample appeared.X-ray fluoroscopic inspection of the cracked sample was performed.It was found that the crack similar to the actual sample was simulated on the tube inside the female connector.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, it was confirmed that a crack was found in the connecting part between the female connector and tubing on the sampling line.As a possible cause of the crack on the tube, it was inferred that some impact load was applied to the female connector that exceeding the limit strength of product.However, from the condition of actual sample, it was not possible to clarify exactly when the crack occurred.The instructions for use (ifu) (capiox fx25) has the following cautions: "do not use if the package or device is damaged (e.G., cracked) or any of the port caps are off." "if the product is dropped during set-up, do not use it.Replace with another device.".
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