Events

Alerta De Seguridad para External sewage pump Architect no. List 8C94-99. External sewage pump Aeroset no. List 9D61-01

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil LTDA.

¿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
    713
  • Fecha
    2003-03-26
  • 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
    For laboratories that do not use an external sewage pump, there are no actions to be taken. There are no maintenance procedures that require operator intervention at the pump. Caution: When handling the sewage pump, ensure that adequate personal protective equipment is used. As a precaution, avoid contact with the metal end of the external sewage pump.
  • Causa
    The abbott laboratories - diagnostic division has identified a potential risk in handling the external sewage pump used in the architect and aeroset systems. this pump is an optional component for use in architect and aeroset systems. the metal end around the perimeter of the sewage pump can cause scratches or cuts if not handled with care.
  • Acción
    Corrective actions are being implemented to eliminate this potential risk. External sewage pumps currently in use will be reviewed by ABBOTT representatives for removal of any end that poses a potential hazard.

Device

External sewage pump Architect no. List 8C94-99. External sewage pump Aeroset no. List 9D61-01

Manufacturer

Abbott Laboratórios do Brasil LTDA
  • Source
    ANVSANVISA