Recall of Aquarius Hemodialysis System

From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts
Recall of Aquarius Hemodialysis System
Emma Hitt, PhD
Authors and Disclosures
Posted: 01/29/2010

January 29, 2010 — A class 1 recall of the Aquarius Hemodialysis System has been announced by the manufacturer, Edwards Lifesciences, LLC, and the US Food and Drug Administration (FDA).

The recall is being made "due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm," according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

The recall was initiated on January 11, 2010, and extends to organizations and companies who received the product, as well as those who "may have received the potentially affected devices through a transfer."

The affected model numbers are GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using software version 6.00.04. The product was manufactured from July 12, 2007, through March 18, 2009, and distributed from July 12, 2007, through March 18, 2009.

"When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm," according to the alert. "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."

The company plans to upgrade software to prevent users from bypassing the fluid balance alarm more than 5 times in a 20-minute period.

More information is available on the FDA's Web site.

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.

Baxter International, Inc, distributes the system for Edwards Lifesciences, LLC. For questions regarding the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543.

Adverse events related to this hemodialysis system should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.