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

¿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
    Baxter Hospitalar informed the Technovigilance Unit that it has already begun contact with the clients involved, via a communication letter. According to Baxter, an example of a situation that may lead to buffer overflow would be when all three channels are simultaneously infusing fluid, with both the dose and flow check modes enabled, while a titration is performed in the mode or while an alert is being solved. The mono-channel Colleague pumps are not affected by this problem and may be used as a replacement alternative for the triple-channel Colleague pumps, if available. The Technovigilance Unit is following up on this case.
  • Causa
    Colleague triplo canal infusion pumps may have their infusion interrupted under certain specific conditions of use. this observed event is related to a buffer saturation of the triple channel colleague infusion pumps, generating the interruption of the infusion with a failure code notification (16: 310: 867: 0002) and with a visual and audible alert.
  • Acción
    According to Baxter Hospitalar Ltda, the actions to be taken to minimize the possible risks of infusion interruption are as follows: (1) If the dose mode function is used in your Triple Channel Colleague pumps, use only two of the three pump channels. It is necessary to keep in mind that it is not possible to permanently deactivate the third channel of the Coleague Triple Channel infusion pump; Baxter can offer options to its customers to prevent the loading and use of the third channel if necessary. (2) If the dose mode function is not used in your Triple Channel Colleague pumps, disable this option or contact Baxter Ltda to help you implement this action. Temporarily, while the dose mode is off, use only two of the three pump channels.


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