Alerta De Seguridad para CARDIOPLEGIA CANNES SARNS. Models: 203895, 203861 and 203887. Registry Anvisa: 80012280008. See list of affected lots in the Alert Message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7c2181004c05651f8c4ddcdc39d59d3e/Message + of + Alert + 1150.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 TERUMO MEDICAL 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
    1150
  • Fecha
    2012-07-17
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Additional information in the Alert Message disclosed by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7c2181004c05651f8c4ddcdc39d59d3e/Message+of+Alerta+1150.pdf?MOD=AJPERES. #### Update (01/11/2012): The company reported having located 296 affected units of the product remaining in the market. The date of destruction of these collected units will still be confirmed by the company. #### Update (09/04/2013): The field action was completed by the record holder on 11/27/2012. There were collected 276 units of product under risk, which were destroyed according to Certificates of Treatment presented by Terumo Medical do Brasil Ltda.
  • Causa
    Presence of foreign substance on surface of product.
  • Acción
    It is a collection of product, aiming at its destruction. Check in your stock if you have products affected by this field action. If so, segregate and identify them to avoid inadvertent use, complete and submit the Response Form provided by Terumo and contact the company to receive instructions for the referral of the segregated products.

Manufacturer