On January 28, 2010 the Food and Drug Administration notified healthcare professionals of a recall on Edwards Lifesciences Aquarius Hemodialysis Systems because users can override the fluid imbalance alarm resulting in a change in the volume of circulating blood. This can result in serious injury or death.

A hemodialysis system cleans waste products and extra fluid in a patient’s body after kidney failure, and monitors all the fluid going in and out of the body.  The system should trigger an alarm if there is an imbalance of fluid in a patient’s body.  The problem is that patients can override the alarm accidentally.

Healthcare professionals, especially nephrology and hemodialysis healthcare professionals should be aware of the potential risks while using this equipment. The  model numbers affected are: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04.

To fix the problem the company plans a software upgrade that will prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.

If you have any questions about possible issues resulting from a hemodialysis system for yourself or a loved one, contract a Philadelphia Malpractice Attorney.