Events

Alerta De Seguridad para bags for collection and blood infusion

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Fresenius Kabi Ag || Fresenius Kabi (Guangzhou) Co., Ltd. || Fresenius Hemocare C.Z. S.R.O || Fresenius Hemocare Brasil Ltda. || Fresenius Hemocare Austria Gmbh || Fresenius Hemocare Netherlands B.V.

¿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
    R1703-97
  • Número del evento
    2009DM-0004196
  • Fecha
    2017-03-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that the bags have presented dehongos growth on the label of the primary packaging, however it clarifies that the sterility of the product is not compromised, leading to the occurrence of potentially adverse events on the patients.

Device

bags for collection and blood infusion
  • Modelo / Serial
  • Descripción del producto
    Conventional bags and TOP AND BOTTOM equipment for collection, processing, leucorreduction and infusion of whole blood, red blood cells, fresh frozen plasma, platelet concentrate and cryoprecipitate. It comes with cpda-1 or CPD anticoagulant and SAGmanitol as a preservative solution. In conventional presentation of simple equipment (whole blood); double (red blood cells and plasma) triple (red blood cells, plasma and platelets) and quadruple (red blood cells, plasma, platelets and cryoprecipitate) and transfer. TOP ANDBOTTOM for leucorreduction in triple presentation (red blood cells, plasma) quadruple (red blood cells, plasma, platelets) and quintuple (red blood cells, plasma, platelets). Collection capacity 450 ml +/- 45 ml of blood. The bags serve for infusion of blood or its components.
  • Manufacturer
    Fresenius Kabi Ag || Fresenius Kabi (Guangzhou) Co., Ltd. || Fresenius Hemocare C.Z. S.R.O || Fresenius Hemocare Brasil Ltda. || Fresenius Hemocare Austria Gmbh || Fresenius Hemocare Netherlands B.V

Manufacturer

Fresenius Kabi Ag || Fresenius Kabi (Guangzhou) Co., Ltd. || Fresenius Hemocare C.Z. S.R.O || Fre...