BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice for the HomeChoice/HomeChoice PRO automated peritoneal dialysis systems, Baxter

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 01641/14

The company Baxter issued a Field Safety Notice concerning a new warning labeling for peritoneal dialysis systems HomeChoice/HomeChoice PRO. The additional warning refers to unintended Increased Intraperitoneal Volume (IIPV) when treating specific populations which are more vulnerable to the negative effects of excessive retention of fluid.

Safety Notice for the HomeChoice/HomeChoice PRO automated peritoneal dialysis systems, Baxter , Download_VeroeffentlichtAm_EN PDF, 92KB, File does not meet accessibility standards