Edwards Lifesciences Recalls Aquarius Hemodialysis System

A medical device used to remove waste and excess fluids from kidney failure patients is being recalled following reports of potentially dangerous fluid imbalances in some patients, the Food and Drug Administration.

The Aquarius Hemodialysis System, made by Edwards Lifesciences of Irvine, Ca., also monitors fluid levels entering and leaving the patient. The company and the FDA have initiated a Class I recall, the most severe such safety action the agency can take, which is reserved for cases in which the FDA determines it is likely serious injury will occur from continued use of the recalled product.

Some users of Aquarius Hemodialysis System have said they have been able to repeatedly override the device’s fluid imbalance alarm, which could affect the volume of circulating blood and result in serious injuries or death, the FDA said.

Specific Models Recalled

The recall includes the following model numbers of the medical device: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800 using software version 6.00.04. The recalled products were distributed from July 12, 2007 through March 18, 2009 by Baxter International, Inc., the U.S. distributor of the Aquarius.

When a specific level of fluid imbalance is detected, the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy, the FDA said. By repeatedly overriding the balance alarm without solving problems 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 the most serious cases, this issue could result in serious injuries or death caused by a decrease or increase in the volume of the circulating blood.

In response to concerns about patients being able to repeatedly override the device’s fluid balance alarm, the company has said a software upgrade will be installed to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period, the FDA said.

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