Events

Alerte De Sécurité sur FEMORAL ACCESS CANULA. Anvisa Registry n ° 80219050017.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA.; EDWARDS LIFESCIENCES LLC.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1528
  • Date
    2015-03-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Femoral access cannulae are contraindicated for long-term use (> 6 hours), including extracorporeal membrane oxygenation (ECMO) procedure. The devices are contraindicated for vascular placement outside the femoral artery or vein. As a result, Edwards is adding contraindications to the use instruction included in the products listed below. Request additional information and a copy of the Safety Notice to EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    Edwards lifesciences has identified increased use of the venous and arterial femoral cannula in adult and pediatric populations in an unprecedented manner, which can result in leaks.
  • Action
    The company reviewed the instructions for using the product, alerting to the problem in question. Recommendations to Product Users: (1) Review the Safety Notice sent by the company to understand the changes that Edwards made in the instruction of use and contraindications of the product; (2) Meet with appropriate clinicians in your hospital to review the proper use of the device along with the hazards in using the device unintentionally; (3) Complete and return the knowledge form attached to the letter sent by the company, by email, within 5 business days of receipt of the notification; (4) This notice must be passed on to those within your organization or to any organization whose devices were potentially affected. Please send this notice to other organizations that this action impacts; (5) If you have questions that were not answered, please call Edwards Customer Service. Note: to date the company has not provided a copy of the Security Notice to Anvisa.

Device

FEMORAL ACCESS CANULA. Anvisa Registry n ° 80219050017.

Manufacturer

EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA.; EDWARDS LIFESCIENCES LLC