The U.S. Food and Drug Administration has alerted consumers of the most serious form of recall, a Class I recall, on the Aquarius Hemodialysis System, Edwards Lifesciences' dialysis machine.

On January 11, the Irvine-Calif.-based biotech company sent its customers a recall letter after receiving reports of potentially dangerous fluid imbalances, the FDA reports.

According to the FDA, users are able to override a fluid-monitoring alarm on the blood-filtering device. If done repeatedly, this could let too much or too little fluid pass through, changing the volume of blood in the body. In extreme cases, this could result in harm or even death.
However, the recall appears to be purely precautionary. An Edwards spokeswoman told DOTmed News there have been no reported injuries or deaths associated with the recall.

NOTICE DELIVERED IN MARCH

According to the spokeswoman, last March, Edwards began a voluntary field correction notice, telling customers they were working on a software upgrade to prevent bypassing of the field-imbalance alarm.

This software upgrade stops operators from overriding the alarm more than five times in a 20-minute period, the FDA notes. It received 510 (k) clearance by the FDA last November, according to the Edwards spokeswoman, and will be implemented by Baxter International, Inc., the company that bought the product line from Edwards in September 2009.

Models affected include GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, running version 6.00.04 of the software.

The FDA recall affects fewer than 150 units, according to information Edwards received from Baxter.

The FDA advises that users with questions or concerns should contact Baxter International, Inc., the U.S. distributor of the Aquarius, at 1-888-736-2543.

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