FDA and Edwards Lifesciences has notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm.
The company also said that Baxter International is the US distributor of the Aquarius. The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.
The company said that the recall includes model numbers like GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009.
A Hemodialysis system is used to clean waste products and extra fluid from the body after the kidneys have failed. It also monitors the fluid going into and out of the patient.
The reasons for recalling include the company being received reports of clinically fluid imbalance. It was said that 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.