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 083 04 12 001
  • Fecha de inicio del evento
    2013-05-12
  • 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=3594
  • 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 would like to inform you that an error in the sequence of instructions in the direction inserts for the products listed above has been identified. in section 1 (set placement on cycler) under directions for use, step 1.3 instructs users to remove the protector from the patient line connector on the set prior to connecting solution bags. users should not remove the protector from the patient line connector on the set prior to connecting solution bags. the tip protector should be removed from the patient line connector after priming and immediately prior to connecting the patient line to the transfer set, as described in the in the homechoice and homechoice pro apd systems patient at-home guide. exposure of the patient line during setup can lead to touch contamination resulting in the potential for developing peritonitis. baxter is in the process of updating the direction inserts with the correct sequence of instructions.

Device

Disposable Set Tubing, HomeChoice Disposable Sets
  • Modelo / Serial
    (1) R5C4478 HomeChoice Automated PO Set with Cassette 8-Prong; (2) R5C4479 HomeChoice Automated PO Set with Cassette 4-Prong . update code from MHRA HomeChoice disposable sets: R5C4455, R5C4478,R5C4479, R5C4479E see the attachment.
  • Descripción del producto
    Disposable Set Tubing
  • 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