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 Healthcare.

¿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 062 06 14 001
  • Fecha de inicio del evento
    2016-01-21
  • 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=8802
  • 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
    The manufacturer identified software related issues. detailed description on the issues is available in the attached letter. ........................ ncmdr update action : baxter is sending this communication to announce the release of abacus software version 3.2. baxter will be implementing abacus software version 3.2 at customer facilities as a correction to the issue communicated in our may 7, 2015 safety alert letter, regarding the possibility that the compounder will load the incorrect formula under conditions when two or more different formula files have been created with the same file name.

Device

ABACUS Total Parenteral Nutrition (TPN) Calculation Software
  • Modelo / Serial
    ABACUS Total Parenteral Nutrition (TPN) Calculation software Versions 2.0, 2.1, 3.0 and 3.1 (ABACUS). Product code: 8300-0046, 8300-0047
  • Descripción del producto
    Information Systems, Data Management, Provider Order Entry
  • Manufacturer
    Baxter Healthcare

Manufacturer

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