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 within eight minutes after starting treatment with a revaclear 400 dialyzer, the patient experienced agitation, chest distress, dyspnea, cold sweat, abdominal pain.Blood pressure was 115/60 mmhg, pulse ¿110 times/min regularly¿ and the blood oxygen saturation was 70%.Treatment was discontinued immediately.The patient received oxygen, intravenous dexamethasone (5 mg) and methylprednisolone (40 mg drip).It was reported the patient symptoms ¿were in remission¿ and the ¿patient is stable now¿.No additional information is available.
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