Events

Alerta De Seguridad para FENWAL SEPARADOR AMICUS - Record # 10068390276

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
    810
  • Fecha
    2005-05-12
  • 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 October 2004, the company published a Technical Information document (No. 04-704A) on ammonia-based cleaning products and ammonia. The document informs that these cleaning products should NOT be used on any component of the AMICUS SEPARATOR, and recommended the use of mild soap / detergent. The document is available to customers through Baxter Hospitalar Ltda, telephone 0800-125522 option 3. If you have any questions or concerns about a related event, please contact Baxter Global Technical Services at 0800-125522 - option 3 and with ANVISA - Technovigilance Unit through telephonic 61 - 3448 1485 or tecnovigilancia@anvisa.gov.br.
  • Causa
    Since the launch of the amicus separator, baxter has been using a polycarbonate window in the centrifuge door. this window is protected by a sturdy coating. the company was informed, however, that some customers were using a chemical (specifically ammonia) to clean it. using this type of cleaning material can damage the centrifuge window. it can also accentuate cracks or cracks in the polycarbonate. so far there has been no news of any adverse events caused by this situation.
  • Acción
    The company is replacing the centrifuge window of all AMICUS SEPARATOR instruments.

Device

FENWAL SEPARADOR AMICUS - Record # 10068390276

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA