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 Baxter Corp Canada.

¿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 054 06 17 000
  • Fecha de inicio del evento
    2017-06-15
  • 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=4&rid=11184
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    After a planned sharesource outage on may 28, 2017, three issues occurred: - the patient consent to share data was required, even though there was no revision of the patient consent content. a failure to submit a patient consent through the claria cycler resulted in patients being prompted to enter the patient activation code (pac) before each treatment, and no treatment data from the claria is shared with the clinic. - clinicians saw incorrect message “not for human use” on sharesource website. - some reviewed treatment history was not visible; those treatments were no longer marked as “reviewed”.

Device

Sharesource Claria Connectivity Platform for Use with Homechoice Claria APD System
  • Modelo / Serial
    Product Code# 5CGM01
  • Descripción del producto
    home dialysis therapy
  • Manufacturer
    Baxter Corp Canada

Manufacturer

Baxter Corp Canada
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Representante del fabricante
    Arabian Health Care Supply Co. (AHCSC) Riyadh (01) 4747444
  • Source
    SFDA