Events

Alerta De Seguridad para INFUSION PUMP COLLEAGUE TRIPLE CHANNEL. Anvisa Registry: 10068390320.

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
    940
  • Fecha
    2008-09-24
  • 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
    In July 2007 Baxter Healthcare Corporation identified an irregularity related to the saturation condition of the buffer memory of the Colleague Triple Channel infusion pumps, which may cause these devices to interrupt the infusion under certain circumstances. Such irregularities may occur in Triple Channel Colleague equipment using the version (s) of Vista Balance software, Master 5.46 and Slave 4.02. For further information, please refer to the Notice of Technovigilance n ° 888. According to a recent company announcement to UTVIG / ANVISA, the root cause of the problem has been identified and the defects of the software have already been solved by Baxter Healthcare Corporation.
  • Causa
    Possibility of saturation of the buffer memory of the equipment / warning about incorrect use of batteries.
  • Acción
    Baxter Hospitalar Ltda started on September 15, 2008 a field action with the objective of updating software and part of the hardware of the Colleague Triple Channel infusion pumps. The action applies to all these equipment already marketed in Brazil. For further details on product changes, refer to Appendix 01 - Customer Letter of this alert. In addition, the company has informed UTVIG / ANVISA that NP2-12 batteries not purchased directly from Baxter and / or batteries labeled "Not indicated for medical use" should not be used with Colleague equipment.

Device

INFUSION PUMP COLLEAGUE TRIPLE CHANNEL. Anvisa Registry: 10068390320.

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA