Events

Alerta De Seguridad para DOUBLE BAG CPDA-1 with sample collector - (ANVISA Register: 10154450076) - Affected lot: 71CD15AA; TROPICAL CANCER CPDA-1, platelets 5 days, with sample collector - (ANVISA Record: 10154450085) - Affected lots: 71CD14AB, 71CD14AC, 71CD14AD, 71CD17AB, 71CD17AC, 71CD17AD, 71CD17AE, 71CD17AF, 71CD18AA; CPDA-1, 5-day platelets, with sample collector - (ANVISA Record: 10154450085) - Batch Affected: 71CD17AA; TRAGLA CPD / SAG-M, platelets 5 days, with sample collector - (ANVISA Record: 10154450072) - Affected lots: 71CD16AA, 71CD16AB, 71CD16AC, 71CD16AD, 71CD16AE, 71CD16AF.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fresenius Hemocare do Brasil 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
    964
  • Fecha
    2009-07-06
  • 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
    According to the manufacturer of the product, corrective measures to solve the problem in the production process are already being taken. The entire process of withdrawal from the market, rework (where possible), testing and re-release was carried out in accordance with good practices. manufactured and monitored and documented by local health surveillance. It was performed inspection and sent report, as well as the publication in DOE with the respective release.
  • Causa
    Perforation in the wall of blood bags with consequent extravasation of anticoagulant or biological material.
  • Acción
    Users are advised to take the following actions: (1) Check the inventory for products at risk listed in the Product Description field of this alert; (2) Segregate and identify the products at risk located; (3) Contact the supplier / recorder of the product. According to information from the record holder of the product, the affected batches of the product have already been withdrawn from the market by means of a Letter of Communication to customers.

Device

DOUBLE BAG CPDA-1 with sample collector - (ANVISA Register: 10154450076) - Affected lot: 71CD15AA...

Manufacturer

Fresenius Hemocare do Brasil Ltda.