Events

Rappel de Device Recall EDWARDS AQUARIUS HEMOFILTRATION SYSTEM

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Edwards Lifesciences, Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53554
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0653-2010
  • Date de mise en oeuvre de l'événement
    2009-03-16
  • Date de publication de l'événement
    2010-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85849
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Cause
    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
    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.

Device

Device Recall EDWARDS AQUARIUS HEMOFILTRATION SYSTEM
  • Modèle / numéro de série
    Model GEF09800 all units/serial numbers.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Edwards Lifesciences Aquarius System Model GEF09800.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Adresse du fabricant
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA