Alerta De Seguridad para VENOUS CANAL SARNS / ANVISA Registry n ° 80012280001 ;. ARTERIAL CANAL SARNS / ANVISA Registry n ° 80012280011.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Terumo Cardiovascular System Corporation.

¿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
    1402
  • Fecha
    2014-07-25
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 presence of loose fiber particles on the surface or within the cannula may be difficult to detect by users. Such particles may settle in the patient's vascular system, resulting in varying degrees of damage, depending on the size of the material, the location in which it was deposited, and the condition of the patient. Potential results include particle embolism or an inflammatory response that can cause blood clots, ischemia, or tissue death. #### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Causa
    Presence of loose fiber particles that exceed terumo's finished product specifications.
  • Acción
    Collection and destruction of the product. Users should stop using the products immediately, segregate them from their inventory quickly, and return them to distributors.

Manufacturer