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 approximately 30 minutes after starting treatment with a polyflux 14l dialyzer, the patient experienced a cold sweat and abdominal pain.Treatment was discontinued.It was reported the dialyzer was replaced immediately (no further details).It was reported the patient was treated with an intramuscular injection of phenergan 25mg and intravenous dexamethasone 5 mg for the event.No additional intervention was reported.At the time of this report, the patient outcome was reported as stable.No additional information is available.
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