Events

Retiro De Equipo (Recall) de Edwards Lifesciences QuickDraw Venous Cannula

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00524-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00524-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Through routine post market surveillance data review, edwards lifesciences has identified new risks associated with specific removal techniques for the quickdraw venous cannula product:1. scar tissue at the incision site may create resistance and increase the withdrawal forces on the cannula.2. when using the percutaneous technique; separation of the cannula may occur during removal if too much compressive force is applied at the incision site. this is in addition to the resistance felt if scar tissue is present.
  • Acción
    Edwards Lifesciences is asking customers to quarantine any affected product and return these. Cautions for these new risks are being added to the IFU for future shipments of the cannula to provide information to users about this potential risk.

Device

Edwards Lifesciences QuickDraw Venous Cannula

Manufacturer

Edwards Lifesciences Pty Ltd