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 Lundia AB.

¿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 039 11 16 000
  • Fecha de inicio del evento
    2016-11-06
  • 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=10188
  • 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
    Baxter ag is issuing a voluntary urgent device correction for ak 98 dialysis machines due to two software issues. : i. the machine could become stuck in a fluid by-pass state if the operator confirms the air detector alarm during priming. in a fluid bypass state, the fluid path bypasses the dialyzer and no ultrafiltration (uf) or diffusion occurs, leading to an absence of treatment. ii. the ultrafiltration supervision (ufs) may be put in an idle (non-functional) state, if the functional check of the blood module is delayed and is completed after the functional check of the fluid module.

Device

AK 98, 230V, Bio
  • Modelo / Serial
    Product Name: AK 98, 230V, Bio Product Code: 115248 Serial Numbers: All (please refer to attached affected customers list).
  • Descripción del producto
    Dialysis machine
  • Manufacturer
    Gambro Lundia AB

Manufacturer

Gambro Lundia AB
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Representante del fabricante
    Baxter AG
  • Source
    SFDA