Events

Alerta De Seguridad para AUTOMIX Automated Nutrition Mixer. Models: AUTOMIX, AUTOMIX 3 + 3, AUTOMIX PLUS, AUTOMIX 3 + 3 230V AND AUTOMIX 3 + 3 / AS.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Hospitalar 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
    1158
  • Fecha
    2012-08-02
  • 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
    According to the Company, a corrective action was initiated in March 2011 through a Letter of Communication to Customers, informing about a potential failure in the equipment keyboard. Subsequently, on 06/06/2012, the Company verified that this action was not effective and, in addition, identified that the AUTOMIX system could suffer an intermittent electric fault, which may cause a sudden and unexpected stop of the product - this may lead to interruption of the mixing process performed by the product, without any alarm or "green" warning light visible, without the operator detecting the fault.
  • Causa
    Possibility of intermittent electric failure.
  • Acción
    The record holder started collecting the product. If you have any product affected by this field action in your inventory, check Baxter's recommendations for product use in the Letter to Customer. To access the Letter to the Client, use the following link: http://portal.anvisa.gov.br/wps/wcm/connect/e6fdba004c34776ca906f9dc39d59d3e/Mensagem_de_Alerta.pdf?MOD=AJPERES

Device

AUTOMIX Automated Nutrition Mixer. Models: AUTOMIX, AUTOMIX 3 + 3, AUTOMIX PLUS, AUTOMIX 3 + 3 23...

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA