It was reported that a patient being treated with a polyflux 170h dialyzer, experienced abdominal pain (described as similar to premenstrual syndrome abdominal cramp), sweating and a drop in blood pressure.The patient was treated with an unspecified antihistamine, but the symptoms persisted.It was reported that after blood return was performed, the patient was switched to a different dialyzer brand, and the symptoms resolved.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Additional information: h6 and h10.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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