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 a patient experienced an allergic reaction within 10 minutes of starting dialysis treatment.The symptoms reported were sweats, abdominal pain, decrease in blood pressure and cold sweat.The treatment was stopped immediately and dexamethasone 10 mg and intramuscular phenergan 25 mg were given to the patient as treatment.It was reported the patient was "stable".No additional information is available.
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