Events

Alerta De Seguridad O Notificaciones De Seguridad para Animas IR1200, Animas IR1250 and Animas 2020

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Animas.

¿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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/003
  • Número del evento
    CON226927
  • Fecha
    2013-01-22
  • Fecha de publicación del evento
    2013-01-22
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON226927?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    The pumps will only operate until 31 december 2015 due to a software problem. from 1 january 2016 the pumps will not deliver insulin and will generate a call service alarm. the manufacturer has stated that this software issue will not affect pumps prior to 1 january 2016. further information is available in the manufacturer’s field safety notice (fsn) dated 12 november 2012.
  • Acción
    Identify affected devices. Ensure that staff and patients who are affected are aware of this problem. Contact the manufacturer to arrange for replacement pumps.  Please note that they will only be providing free-of-charge replacements for pumps that are within warranty. Ensure that all affected pumps are replaced before 31 December 2015. Diabetes departments Pharmacists Those involved in the procurement, supply and use of this device.

Device

Animas IR1200, Animas IR1250 and Animas 2020
  • Modelo / Serial
  • Descripción del producto
    Ambulatory insulin infusion pumps. Animas IR1200, Animas IR1250 and Animas 2020. All serial numbers . Animas no longer distributes the IR1200, IR1250 or the 2020 models in the UK. Affected pumps will be replaced with a different model of Animas insulin infusion pump. Animas will be providing training on the use of the replacement pumps. The manufacturer considers pumps that are outside the warranty period to have exceeded their expected life, and so will only be providing free-of-charge replacements for pumps that are still within warranty on 31 December 2015. Please note that all IR1200 and IR1250 pumps will be out of warranty by 31 December 2015.
  • Manufacturer
    Animas

Manufacturer

Animas