Events

Alerta De Seguridad para CATETER FOR BLOOD PRESSURE MONITORING. Model: C-PMS-300-RA; C-PMS-250; C-PMS-400-RA; C-PMS-400-FA; C-PMS-250-RA, registration 10212990205; risk class II. Lots / Series: 5810917; 5824548, 5824547; 5,810,905; NS6014457; NS6047399; NS6047398; NS6047397; NS6047396; NS6045805; NS6047442; NS6047440; NS6014456; 6067782; NS6063331; NS6063328; NS6108226

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por E. Tamussino & CIA.; Cook Incorporated.

¿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
    1817
  • Fecha
    2016-02-12
  • 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
    The recall was performed because it could cause potential serious adverse events.
  • Causa
    There may be separation of the catheter tip, which may lead to loss of device function and obstruction of blood flow to terminal organs.
  • Acción
    Gathering and destruction. Action code T10071-36 and T10071-37. The manufacturer directs not to use the product and to communicate the company as soon as possible so that the necessary measures are taken.

Device

CATETER FOR BLOOD PRESSURE MONITORING. Model: C-PMS-300-RA; C-PMS-250; C-PMS-400-RA; C-PMS-400-FA...

Manufacturer

E. Tamussino & CIA.; Cook Incorporated
  • Source
    ANVSANVISA