Recall Z-0653-2010 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Edwards Lifesciences, Llc
Edwards Lifesciences Aquarius System Model GEF09800.
| Date | Jan 27, 2010 (initiated Mar 16, 2009) |
| Status | Terminated |
| Reason | 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 | Employee error |
| Action | 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 d |
| Quantity | 135 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070320 | EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 Edwards Lifesciences Services GmbH, Jun 7, 2007 |