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 10 minutes after starting dialysis treatment with a revaclear 400 dialyser, a patient experienced nausea, cold sweat, a drop in blood pressure and "trance".No medical intervention was reported.At the time of this report, the patient outcome was reported to have stabilized.There was no patient injury or medical intervention associated with this event.No additional information is available.
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