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# mh4z4l.As a result, no abnormality was found in records.1,380 units of this lot# mh4z4l were manufactured, and no similar event using this lot# mh4z4l was reported globally.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): 12.Hemolysis is an adverse reaction that can occur if the tmp increases above 100mmhg (13.3kpa).13.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.쳌e 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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A patient was in the condition of chronic renal failure in (b)(6).The patient was planned to have a kidney-transplant surgery, and double filtration plasmapheresis (dfpp) treatment was required to performed because of the patient's high level of antibodies.(b)(6) 2019: after 10 minutes from the blood was introduced to the circulation of dfpp using plasmaflo op-08w used as plasma separator, which is similar product of plasmaflo op-05w(a) marketed in us, bright red liquid was observed in the plasma-room.The doctor thought it may be a hemolysis reaction, and the treatment was stopped.The liquid sample was sent for further test (hemolysis was confirmed).The patient recovered.
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