Events

Retiro De Equipo (Recall) de FemoSeal Vascular Closure System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Terumo Australia 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-2017-RN-01092-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-08-22
  • 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-2017-RN-01092-1
  • 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
    Terumo medical corporation has received an increase in device related malfunction complaints for femoseal vascular closure systems. specifically, after the deployment of the inner locking disc, the complaints state that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure.An investigation by terumo has identified that the internal suture becomes entrapped as a result of operator miss-assembly during device manufacture and that this issue then only becoming visible midway through device deployment.
  • Acción
    1. Review the urgent medical device recall notification and distribute to all staff working with this equipment. 2. Inform any facilities that may have received this product of the recall action. 3. Quarantine all product in the affected population, record the lot number and quantity on the Customer Response Form supplied with the Customer Letter 4. Place quarantined product in a secure location for return to Terumo Australia Regulatory Affairs Department. 5. Package and return all affected product via courier

Device

FemoSeal Vascular Closure System
  • Modelo / Serial
    FemoSeal Vascular Closure SystemAll non-expired productProduct Code: C11202Multiple Lot NumbersARTG Number: 263892
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd