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 Codan Argus AG.

¿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 05 14 000
  • Fecha de inicio del evento
    2014-05-13
  • 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=5&rid=5823
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The basis of this field safety notice are pertaining to the frequent technical errors #8123 and #8129 on codan argus 717v infusion pumps. technical errors #8123 and #8129 originate from the self-test of the down-stream pressure sensor. analysis by the manufacturer revealed that apart from broken pressure sensors, excessive hardness of the intravenous infusion set could trigger these technical errors. the technical errors occur once the intravenous infusion set is inserted and the user closes the pump door - before the infusion is started. any such delay of infusion or interruption of therapy through a false infusion pump alarm, which may potentially put the patient’s health at risk, is unacceptable. unanticipated variations of the mechanical properties of the intravenous infusion sets were identified as the root cause of above mentioned false technical errors.

Device

Infusion pump CODAN ARGUS 717/718V
  • Modelo / Serial
    Control software version 5.05
  • Descripción del producto
    Infusion pump, multifunction
  • Manufacturer
    Codan Argus AG

Manufacturer

Codan Argus AG
  • Empresa matriz del fabricante (2017)
    Codan Argus Ag
  • Representante del fabricante
    Al-Jeel Medical & Trading Co. LTD, Riyadh (011) 4041717
  • Source
    SFDA