Events

Alerta De Seguridad O Notificaciones De Seguridad para Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails

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 CareFusion.

¿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/2013/062
  • Número del evento
    CON300410
  • Fecha
    2013-08-08
  • Fecha de publicación del evento
    2013-08-08
  • 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/CON300410?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
    Risk of interruption to therapy. a fault with the front and rear bearings of the pump’s stepper motor may cause the pump to stall during an infusion. the pump stops, alarms and displays a ‘drv1’ or ‘drv2’ error on the screen. replacement of the motors will begin in september 2013. carefusion issued a field safety notice (fsn) in may 2013. the motor stall condition may occur during start-up (immediately after the start key is pressed) or during an infusion, which may result in the early termination of an infusion. early termination of an infusion could require intervention especially if critical drugs are being administered.
  • Acción
    Identify affected pumps. Consider using an alternative pump, particularly if an interruption to an infusion could compromise patient safety. If an alternative pump is not available, follow the advice in the manufacturer’s instructions for use. In particular if a ‘DRV1 or DRV2’ error is displayed, immediately remove the pump from use and contact CareFusion. Return completed verification form in the FSN to CareFusion. When available, ensure the stepper motors are replaced.

Device

Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails
  • Modelo / Serial
  • Descripción del producto
    Infusion pumps: Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Specific serial numbers are affected. General purpose volumetric infusion pumps intended for acute and sub-acute applications. Product codes: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G. The serial numbers of affected pumps are specific to each customer. Contact your local biomedical engineering department to obtain this list or contact CareFusion directly to determine which pumps are affected. The serial number is printed on the back of each pump. The MHRA does not possess a list of affected serial numbers.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion