Events

Alerta De Seguridad para Information System, Distribution Information Program and Components of the Blood Bank Stand-Alone System. All versions up to and including version 1.1.1

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

¿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
    183
  • Fecha
    2000-10-27
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The blood bank program mentioned has a defect that does not assign all special donation properties to all donated products. the manufacturer initiated a telephone recall on july 5, 2000, followed by letters sent on july 7, 11 and 17, 2000. the company did not provide any information to ecri.
  • Acción
    Make sure that you have received the mailings that were sent on July 7, 2001 and July 7, 2000, by Information Data Management. Identify and isolate any affected product from your inventory. For more information, contact your local representative or directly with Information Data Management at 1 (847) 825-2300 in the United States. ECRI recommends that you do not use this system until the company corrects the protocol to ensure proper processing and documentation.

Device

Information System, Distribution Information Program and Components of the Blood Bank Stand-Alone...

Manufacturer

Information Data Management
  • Source
    ANVSANVISA