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 022 05 18 000
  • Fecha de inicio del evento
    2018-05-07
  • 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=12573
  • 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
    Terumo states that if a blood warmer is attached to the tubing set of the above apheresis systems and the blood warmer is not primed before use, air could be delivered to a patient. the firm is reinforcing actions required to mitigate this risk. terumo states that many spectra optia procedures include the option to use a blood warmer. the spectra optia operator's manual instructs operators how to connect and prime a blood warmer when one is used. the operator's manual also includes warnings about the risk of delivering air to a patient if a blood warmer is not primed. further details are provided in attached letter.

Device

Spectra Optia Apheresis Systems
  • Modelo / Serial
    Apheresis Systems Spectra Optia 61000
  • Descripción del producto
    Apheresis Units, Blood Donor, Plasma , Therapeutic, Platelet/Plasma Exchange , White Blood Cell
  • Manufacturer
    Terumo BCT Inc.

Manufacturer

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