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 Terumo BCT Inc.

¿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 057 12 18 000
  • Fecha de inicio del evento
    2018-12-16
  • 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=13622
  • 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
    This letter provides information about the new iv pole collar accessory for the spectra optia system. new spectra optia systems will be shipped with an iv pole collar (see figure 1 below in the attached fsn). this feature has been added to avoid a pinch point between the iv pole and the machine while lowering the iv pole. if the operator does not hold onto the iv pole while pressing the iv pole release button, the iv pole may drop in a free fall. if the operator’s hand or any other body part is in the path of the free-falling iv pole, the operator could be injured. because this is an added safety feature, do not remove the collars after they are installed on the iv pole.

Device

Spectra Optia® Apheresis System
  • Modelo / Serial
    Spectra Optia® Apheresis System
  • Descripción del producto
    Apheresis Units, Blood Donor
  • Manufacturer
    Terumo BCT Inc

Manufacturer

Terumo BCT Inc
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA