It was reported that approximately 30 minutes after starting treatment with a revaclear 300, the patient experienced nausea, vomiting, and the blood pressure dropped to 78/56 mmhg (from 172/89 mmhg).The ultrafiltration was stopped, and 200 ml of water was returned to the patient.The patient was administered dexamethasone (10 mg).It was reported 10 minutes later, the patient's blood pressure was 143/86mmhg.No symptoms of nausea or vomiting were reported after the intervention.No additional information is available.
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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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