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 during use of a polyflux 140h.The patient experienced an increased heart rate, dyspnea and cold sweat within 30 minutes of starting dialysis treatment.The treatment was stopped immediately.The patient received intravenous dexamethasone 10 mg, drop 0.9% gs 100ml with 30ml calcium gluconate and oxygen.Sixty minutes later, the symptoms were in remission.No additional information is available.
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