Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Gambro..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 034 01 11 000
  • Fecha de inicio del evento
    2011-01-17
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=49
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The patient / priming detector is integrated in the venous clamp. if the start up procedures for on-line priming described in the operator's manual are not followed when preparing the ak 200 ultras and ak 200 ultra machines for a patient treatment, a significant safety feature may be compromised, in which case the device may not be able to detect blood. this issue may arise if the operator: -fails to properly attach the venous line in the venous clamp during the priming procedure; and -fails to verify the illumination of the machine blood path indication after patient connection; and -fails to confirm start of treatment; and - ignores the audible alarm and attention related to the achieved extra priming volume.

Device

HAEMODIALYSIS SYSTEMS.
  • Modelo / Serial
    AK 200 ULTRA S with software 9.20 or older AK 200 ULTRA with software 8.00 or older
  • Descripción del producto
    HAEMODIALYSIS.
  • Manufacturer
    Gambro.

Manufacturer

Gambro.
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Representante del fabricante
    Arabian Medical Marketing Co. (AMCO), Riyadh, (01) (01) 4887122
  • Source
    SFDA