In light of recent events the BfArM would like to draw your attention once again to the possible occurrence of severe hypersensitivity reactions caused by dialysis filters. There may be life-threatening events due to rapidly occurring anaphylaxis (type I reaction / usually occurring in the first minutes after dialysis) or late reactions (type IV reaction / occurring approximately 15-20 minutes after dialysis), whereby the late reactions usually have a less severe course. The majority of hypersensitivity reactions are triggered by dialysis filters containing polysulfone membranes. The German Society for Nephrology (DGfN) has published up-to-date information on the subject at the following link.
BfArM recommends adjusting the treatment parameters according to the manufacturer's specifications, especially for first treatments, and providing adequate measures for emergency care.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone +49 (0)228 99 307-3202 (Non-active medical devices)
Facsimile +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de