—#85849

Product

Edwards Lifesciences Aquarius System Model GEF09800.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070320
Affected lot / code info: Model GEF09800 all units/serial numbers.

Why it was recalled

There have been 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. It is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this may result in serious injuries or death.

Root cause (FDA determination)

Employee error

Action the firm took

Edwards is continuing a field corrective action related to the possibility of fluid imbalance when using the Aquarius. In order to mitigate some of the risk associated with this problem, Edwards sent notifications to consignees advising of mitigation steps. Consignees were provided: a description of the affected product, problem, and potential hazard; advice on action to be taken; and revised device labeling. Additionally, consignees were notified of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. Although Edwards does not believe there is a need to stop using the Aquarius system at this time, clinicians should weigh the risks/benefits to the patients before continuing the use of the device Edwards first provided some of this information to consignees in a Field Safety Notice on March 16, 2009. On January 11, 2010, Edwards provided an Urgent Product Recall letter to consignees which updated and expanded the earlier communication. The FDA classified this as a Class I recall.

Recalling firm

Firm: Edwards Lifesciences, Llc
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-03-16
Posted by FDA: 2010-01-27
Terminated: 2012-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.