Patient identifier - requested, not provided, age and date of birth - requested, not provided, sex - requested, not provided, weight - requested, not provided, ethnicity - requested, not provided, race - requested, not provided, implanted date: device was not implanted, explanted date: device was not explanted.The actual device was returned for evaluation.Visual inspection revealed no defects.The actual sample, after having been rinsed and dried, was subjected to another visual inspection.No anomaly was confirmed.Colored saline solution was circulated in the actual sample.No leak was detected at any of tube joints.After the above test, the inside of the oxygenator module was pressurized at 1000 mmhg.No leak occurred.Bovine blood was circulated in the actual sample at each blood flow rate of 0.5 l/min., 1.0 l/min.And 1.5 l/min with the back flow rate set to 200 mmhg, while an air of 10 ml was applied to the oxygenator for 30 seconds.There was no outflow of air from the oxygenator module through the filter.After the above test, the fluid level in the reservoir was decreased down to 45 ml and bovine blood was circulated in the actual sample at the flow rate of 1.0 l/min.No entrance of air was confirmed.A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no findings.A search of the complaint file did not find any other report with the involved product/lot combination.The investigation verified that the returned device to be the normal product.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the investigation result, it is likely that the loose connection of the cannula suctioned air into the venous line and the excessive amount of air which exceeded the capacity of the filters in the reservoir and oxygenator flowed into the actual sample and observed in the upper area of the oxygenator module.The device labeling does address the potential for such an event in the instructions-for-use, which states: when capiox fx05 oxygenator module is used separately from the hardshell reservoir, set the module so that the upper end of the fibers is lower than the blood level in the venous reservoir.This prevents gaseous emboli from entering the blood phase from the gas phase.Do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.The gas flow rate should not exceed 5 l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate in the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 0.5 l/min.(b)(4).
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