Medical device manufacturer, Fresenius Medical Care, has issued a medical device safety alert concerning FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers [Reference numbers: F00001593, F00001594, F00001595, F00001588, F00001589].
The manufacturer has observed an increase in number of cases of hypersensitivity and hypersensitivity-like reactions during haemodialysis and haemodiafiltration treatments. These reactions occurred mainly in the first treatment hour or within the first week of treatment, and are potentially life threatening.
The manufacturer is advising users to carefully monitor patients who have not been treated with the affected device or have a history of allergy or asthma. Patients with known hypersensitivity to any of the dialyser's materials must not be treated with the dialysers.
If severe hypersensitivity and hypersensitivity-like reactions occur, the dialysis must be discontinued and the blood from the extracorporeal system must not be returned to the patient.
The manufacturer has also updated the Instructions for Use.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 March 2015