Alerta De Seguridad para (1) Anoxic cryogen; (2) Cryogenic safety equipment

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
  • Causa
    Ecri has received reports of leaks and spills of anoxic cryogen that resulted in death by asphyxia of 2 experienced users. the 2 most used cryogen, liquid helium and liquid nitrogen, are anoxic, so there are risks of suffocation when a certain amount of them is introduced in small or poorly ventilated places. because they are painless and colorless, they are not detectable in their gaseous form, and fatal accidents can occur in the absence of the use of specialized protective equipment. anyone who enters an area filled with one of these two gases without the use of safety equipment will be quickly rendered impossible. signs of asphyxiation are an increase in respiration and heart rate, dizziness, nausea, loss of consciousness leading to loss of consciousness and death.
  • Acción
    ECRI recommends the following: (1) alert users and any other specialized staff to the risks associated with cryogenics. (2) Verify that all safety precautions, procedures, and training are adequate and that they are performed. (3) Verify that O2 monitors are used in all enclosed places where anoxic cryo are handled and stored. (4) Ensure that respiratory protective equipment (breathing apparatus) is always available and make sure there is a means of preventing future leakage or if there is a suspected leak if there is a means to prevent them. (5) Check that all safety equipment is working and checked. (6) Verify that all employees know the procedure when a leak occurs. (7) Ensure that alert signs are readily visible in all places cryogenics are used daily. For more information, please contact your local representative or ANVISA Technovigilance Unit at 0xx61-4481485 or 448.1331 notifying any occurrences associated with these products by completing the Health Product Associated Notices Form available on the Internet -, sending it directly through the Internet or saving the completed file and sending via e-mail to tecnovigilâ If you prefer to print it and send it by fax to 0xx61-4481257.



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