Edwards Lifesciences Aquarius System Model GEF09800.

FDA device recall Z-0653-2010 · posted 2010-01-27 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, Llc

Reason for recall

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

KDI

Quantity affected

135 units

Distribution

Nationwide Distribution.

Date initiated

2009-03-16

Date posted

2010-01-27

Date terminated

2012-01-18

Location

Irvine, CA

Related 510(k) clearances