Events

Alerta De Seguridad para Cannulas

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 Sorin Group Usa Inc..

¿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
    R1706-251
  • Número del evento
    2011DM-0007684
  • Fecha
    2017-06-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • 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 due to an improvement in its monitoring process, it has found that some of the referenced devices may present an excess of plastic at the end of the cannula, if said excess is released during the use of the device it could result in the bloodstream, leading to potentially present adverse events on patients.

Device

Cannulas
  • Modelo / Serial
  • Descripción del producto
    EASY FLOW AORTIC CANCER 23 fr 103-300. Aortic perfusion during cardiovascular surgical procedures that require extracorporeal cardiopulmonary bypass (CPB). EASY FLOW-ARTERIAL DUO CANNULA. WITH GUIDEWIRE 103-310. Extracorporeal circulation, RAP FEMORAL VENOUS CÁNULA 22 fr 200-100. Remote access transfusion. RAP FEMORAL VENOUS CÁNULA, 3/25 fr: 200-150. Remote access, femoral venous perfusion during cardiopulmonary bypass. FLEXFLOW VENOUS CANCER 23 fr 200-200: extracorporeal circulation. VASCULAR DILATOR KIT ESTECH: vascular insertion catheter or cannula kit.
  • Manufacturer
    Sorin Group Usa Inc.

Manufacturer

Sorin Group Usa Inc.
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    NIDFSINVIMA