It was reported that, within 10 minutes of starting therapy with a polyflux 170h, the patient experienced ¿ants crawling sensation¿, a little difficulty breathing, abdominal distension, nausea and vomiting, reported as "for two times".The treatment was discontinued and the patient was treated with dexamethasone 10 mg (intravenous injection) and adrenaline 1 mg (subcutaneous injection).The patient was connected to a new dialyzer to continue with treatment.After 10 minutes of restarting treatment, the symptoms disappeared.The treatment was successfully completed four hours later and the patient went home.No additional information was provided.
|
Additional information: adverse event problem.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.
|