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 Hospira 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 101 03 12 000
  • Fecha de inicio del evento
    2012-03-25
  • 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=1619
  • 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
    Hospira, inc. has received customer reports of bolus delivery failures when using the gemstar bolus cord. possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the bolus cord. potential risk due to failure of the bolus cord is the potential for an unrequested bolus delivery or the failure to deliver requested medication to the patient. the amount of unrequested delivery will be limited by programming lockout volumes. an unrequested narcotic delivery may cause over sedation requiring possible medical intervention, but is unlikely to result in serious or life threatening injuries. the failure to deliver requested narcotic medication may result in the lack of adequate pain relief.

Device

Infusion pump, GemStar Bolus Cord
  • Modelo / Serial
    List Number 13027 Serial no.: All Lot/batch no.: All
  • Descripción del producto
    Infusion pump, Bolus Cord, delivery
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Representante del fabricante
    AL-KAMAL Import, Riyadh, (01) 2181122
  • Source
    SFDA