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 30 minutes after starting dialysis treatment with a polyflux 14l, the patient experienced chest distress, arrhythmia and atrial fibrillation.Medical intervention consisted of an intravenous bolus injection of dexamethasone sodium phosphate (5 mg) and central oxygen inhalation.No additional information is available.
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