Events

Alerta De Seguridad para Colleague Infusion Volumetric Pump. Registro Anvisa n ° 10068390320. Affected series: see attached list in the Client's Notice, available at http://portal.anvisa.gov.br/wps/wcm/connect/af48ba0048438382a757a7bdc15bfe28/Communicado+to+Client+1567.pdf? MOD = AJPERES.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Healthcare S. A. Singapore Branch; 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
    1567
  • Fecha
    2015-05-04
  • 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
    There are no complaints of adverse events or technical complaints related to the problem, however, due to the nature of spare parts, this change could cause a delay or interruption of the infusion (<1: 1000), electric shock or fire (<1: 10000) .
  • Causa
    During the development of field replacement activities for the colleague p1.5 pumps for the most current model p1.7, 23 p1.7 equipment that passed through the technical service of baxter hospitalar ltda received pieces of technology p1.5, that is, they received parts technology.
  • Acción
    The company will carry out field corrections of the affected products. Identify and segregate the affected devices in your product inventory, complete the Customer Response Form (available at http://portal.anvisa.gov.br/wps/wcm/connect/af48ba0048438382a757a7bdc15bfe28/Communicated+to+Customer+1567. pdf? MOD = AJPERES) and send it to Baxter (fax 11-5635-0106 or 0800-012-5522 or by e-mail faleconosco@baxter.com).

Device

Colleague Infusion Volumetric Pump. Registro Anvisa n ° 10068390320. Affected series: see attache...

Manufacturer

Baxter Healthcare S. A. Singapore Branch; Baxter Hospitalar Ltda.