Company:Edwards Lifesciences Inc.br>Date of Enforcement Report 1/11/2010
Class:l
PRODUCT
Edwards Lifesciences “Aquarius” System; Model Numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The Aquarius monitors the fluid going into and coming out of the patient. Recall # Z-0653-2010
This product was manufactured from July 12, 2007 through March 18, 2009 and distributed from July 12, 2007 through March 18, 2009
REASON
The company received reports of clinically significant fluid imbalance.
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. 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. In extreme cases, this could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by letter dated March 19, 2009.
Manufacturer: NIKKISO Medical Systems GMBH, Hannover, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,272 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, Canary Islands, China, Colombia, Czech Republic, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Poland, Romania, Russia, Saudi Arabia, Slovak Republic, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates and United Kingdom
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