It was reported that during dialysis treatment with a polyflux 14l, the patient experienced chest tightness, shortness of breath, sweating, and gradually blurred consciousness.The patient¿s blood pressure decreased from 135/75mmhg to 83/46mmhg, and the oxygen saturation decreased from 99% to 78%.The medical intervention consisted of intravenous methylprednisolone injection 40mg, respiratory skin sac (bag valve mask) assisted ventilation, and 450 ml of 0.9% sodium chloride injection.During the next 25 minutes, the patient¿s condition improved, and the patient was transferred to emergency room for further treatment.No additional information is available.
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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