Events

Alerta De Seguridad para FEMORAL ACCESS CANULA. Anvisa Registry n ° 80219050017.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA.; EDWARDS LIFESCIENCES LLC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1528
  • Fecha
    2015-03-11
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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