Edwards Lifesciences Aquarius Hemodialysis System: Recall - Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Edwards Lifesciences Aquarius Hemodialysis System: Recall - Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm

Edwards Lifesciences Aquarius Hemodialysis System: Recall

Audience: Nephrology and hemodialysis healthcare professionals, hospital risk managers

FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.

The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. 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.

Read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199203.htm

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