It was reported that approximately twenty minutes into the treatment with a polyflux 14l, the patient presented with chest distress, cough and couldn't lay down.The symptoms of patient were remission after a few moments relax.However, after 90 min of treatment the symptoms appeared again and the treatment was immediately stopped.Medical intervention consisted of 5 mg dexamethasone intravenous infusion and oxygen.The patient¿s symptoms were remission and a new dialyzer was used to continue the treatment.No additional information is available.
|
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.
|