Events

Alerta De Seguridad para COLLEAGUE Volumetric Infusion Pump Mono Channel and Triple Channel. ANVISA Register: 10068390320. Product Codes: 2M8151, 2M8151R, 2M8151RT, BRM8151, BRM8151R, BRM8151RT, 2M8153, 2M8153R, 2M8153RT, BRM8153, BRM8153R, BRM8153RT.

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
    956
  • Fecha
    2009-03-09
  • 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
    Baxter is currently developing solutions for correcting the events reported in this letter. The instructions attached to this letter describe further steps to remedy a discontinuation of therapy if it occurs. The ANVISA Technovigilance Unit is monitoring this case.
  • Causa
    1 ° problem: some error codes shown by colleague infusion pumps can lead to interruption of therapy (infusion), which can lead to complications in critically ill patients, including serious injury or death. 2 ° problem: risks associated with inadequate cleaning procedures. 3 ° problem: occurrence of "out of battery" messages.
  • Acción
    The actions recommended to users for each of the reported problems are described in detail in the Letter to Users. Users of COLLEAGUE infusion pumps who do not have a copy of said letter should access it (available at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/956_carta.pdf) and carefully read all instructions, taking the necessary measures to correct / prevent the problems mentioned in this alert.

Device

COLLEAGUE Volumetric Infusion Pump Mono Channel and Triple Channel. ANVISA Register: 10068390320....

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA