FDA
Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401
Kinked tubing on hemodialysis device may cause hemolysis.
On September 10, 2007, the firm sent an Advisory Notice to all consignees alerting them that a kink in the tubing can result in physical hemolysis. The firm included with the Notice a Quick Reference Guide that provides drawing of the proper installation of the Phoenix and describes how to prevent bloodline kinking. A customer reply form was also included. The firm is in the process of making labeling changes that will be released with the updated software revisions.