WASHINGTON—On Jan. 11, the U.S. Food and Drug Administration initiated a Class I recall of the Aquarius Hemodialysis System after reports the machine showed clinically significant fluid imbalances during treatments, according to the FDA.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death, according to the FDA.
“When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm,” according to an FDA notice. “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 could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.”
The machine was manufactured by Irvine, Calif.-based Edwards Lifesciences and distributed in the United States by Baxter International between July 12, 2007, and March 18, 2009.
In a letter sent to customers, Edwards said it has a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.
The recalled model numbers include: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04
Call the Baxter Clinical Help Line at (888) 736-2543 for any questions regarding the Aquarius machine
