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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It was reported that two (02) hours after the start of dialysis treatment with a revaclear 400, the patient experienced itchy throat, uncomfortable cough with no sputum and fever.The nurse reported it "was considered to be a type b allergic reaction".Ultrafiltration was stopped, blood flow was reduced, and the patient was given an intravenous injection of dexamethasone 2.5 mg.The patient's symptoms gradually improved after 10 minutes.After adjusting the ultrafiltration, the dialysis treatment was continued.Four hours after treatment, "the patient had no special discomfort".No additional information is available.
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