It was reported that approximately three hours into treatment with a revaclear 300 dialyzer, a patient experienced a sudden symptomatic haemolysis reported as dark urine, abdominal pain, clamminess and diarrhea.The patient was treated with gaviscon 15 ml, pantoprazole 40 mg intravenously and litalgin 10mg/ml intravenously.Treatment was terminated with blood return, and the patient returned home.It was reported that the patient presented to the hospital the "next day" and was diagnosed with hemolysis and was hospitalized.No medical intervention during the hospitalization was reported.At the time of this report, the patient was reported to have recovered and ¿back to previous condition¿.No additional information is available.
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Additional information: adverse event problem.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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