Involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. Edwards Lifesciences Inc. initiated a Class I recall for its Aquarius Hemodialysis System, effective January 11, 2010, the U.S. Food and Drug Administration (FDA) just announced. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
The recall involves the Edwards Lifesciences Inc. Aquarius Hemodialysis System in model numbers GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. This product was manufactured from July 12, 2007 through March 18, 2009 and distributed from July 12, 2007 through March 18, 2009. Edwards Lifesciences, LLC is located at 1 Edwards Way; Irvine, California; 92614-5688.
A hemodialysis system is used to clean waste products and extra fluid from the body after the kidneys have failed. The system also monitors the fluid going into and out of the patient.
Edwards Lifesciences received reports of clinically significant fluid imbalance
Edwards Lifesciences received reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm; however, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from, or replace too much fluid to, the patient. In extreme cases, this defect could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
On January 11, 2010, the company sent its customers an Urgent Product Recall letter that included the description of the affected product, problem, and potential hazard; advice on action to be taken; revised device labeling; information concerning the planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period; instruction to pass the notice on and inform all other employees within the company/organization who needed to be aware of the problem; and instruction to transfer the notice to other organizations on which this action had an impact and other organizations may have received the potentially affected devices through a transfer.
Baxter International, Inc. is the U.S. distributor of the Aquarius system and can be reached at the Baxter Clinical Help Line at 1-888-736-2543.