This incident occurred in (b)(6) and is reported to fda according to the requirement.Plasmaflo op-08w is similar product of plasmaflo op-05w(a) marketed in us, and is used as plasma separator.We reviewed manufacturing records, quality records of lot# ph6s75.As a result, no abnormality was found in records.No similar event using this lot# ph6s75 was reported globally.The physician considered that this event was serious adverse event of "hemolysis", and the causal relationship between this event and plasmaflo op could not be denied.We could not obtain detail information of this event, according to physician's comment, we considered that this event was serious, and that the causal relationship between plasmaflo op and this event could not be denied because the adverse event occurred during the treatment with op-08w.Hemolysis is described in the package insert of plasmaflo op (i.Preface, e.Precautions): hemolysis is an adverse reaction that can occur if the tmp increases above 100mmhg (13.3kpa).Monitor the patient constantly during treatment with the plasmaflo op-05w(a).In the event of any of the following during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician: presence of hemoglobin in separated plasma, due to hemolysis.We will carefully continue to monitor and to be vigilant for the trend of occurrence of this kind of adverse events.
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This case occurred in (b)(6).The double filtration plasmapheresis (dfpp) treatment was required in order to reduce the patient's antibodies before his kidney-transplant surgery.At about 10 minutes after the start of the treatment of dfpp using plasmaflo op-08w used as plasma separator, which is similar product of plasmaflo op-05w(a) marketed in us, the bright red liquid was observed in the plasma-room of the product.The medical staffs judged that the patient's hemolysis reaction was suspected, his treatment was stopped.No clinical treatment was taken, and he has recovered.
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