(b)(6).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.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
It was reported that a patient being treated with a polyflux 170h dialyzer became unwell 10 minutes into treatment and experienced ants like crawling sensation, difficulty breathing, abdominal distension, nausea and reported vomited twice.An allergic reaction was suspected and treatment was terminated.The patient was treated with 10 mg of dexamethasone intravenously and 1 mg subcutaneous adrenaline injection.After the dialyzing treatment was stopped, the polyflux 170h was replaced with another dialyzer and the patient recovered 10 minutes later.The four hours dialyzing treatment was successfully completed and the patient went home with no discomfort.No additional information is available.
|