Events

Alerta De Seguridad para COLLEAGUE volumetric infusion pump, ANVISA registration number 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
    836
  • Fecha
    2006-07-31
  • 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 Hospitalar Ltda has already begun corrections and updates of the COLLEAGUE infusion pumps in the country with an expected end in July 2007. The company also informs that there were no registered deaths in Brazil related to the equipment. Inquiries regarding COLLEAGUE pumps, please contact Customer Service at 0800 12 55 22, option 3. The Technological Surveillance Unit - UTVIG / NUVIG / ANVISA is following the actions of the company.
  • Causa
    Baxter healthcare corporation is providing a "global update" of colleague infusion pumps.
  • Acción
    Baxter Hospitalar Ltda informs that the "global update" corresponds to: 1. Replacing the User Interface Module printed on the circuit board to solve the Y2A crystal circuit event; 2. Install from a new version of the software to obtain the following: a. Limit the battery discharge after 3 minutes in the dead battery alarm status. B. Increase visual indicators and battery messages to allow a better understanding of current battery charge levels. w. Include a confirmation window that will appear when the user attempts to turn off the pump. d. Troubleshoot external communications port errors. 3. Replace battery wiring to the extent necessary to reduce the possibility of battery deformation. New batteries will be installed in the pumps as part of this action; 4. Modify the upper jaw of the pump pumping channel to reduce the possibility of insufficient infusion; 5. Perform a review of all pumps to ensure that all previous modifications have been made; 6. Provide with each pump a corrected Operator's Manual reflecting all the updates performed and where the instructions are clarified.

Device

COLLEAGUE volumetric infusion pump, ANVISA registration number 10068390320.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA