Events

Alerta De Seguridad O Notificaciones De Seguridad para GemStar infusion system

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 Hospira.

¿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/2014/010
  • Número del evento
    CON392878
  • Fecha
    2014-03-13
  • Fecha de publicación del evento
    2014-03-13
  • 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/CON392878?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 delay to patient therapy due to loss of audio alarms. the connection between the beeper subassembly and pump may fail so that only visual alarms will be available. the pump will only identify the beeper failure during ‘self-test’ whilst powering up, which will prevent it from being programmed or used. pumps that were previously fixed for this beeper failure may fail again.
  • Acción
    Use an alternative pump, where available. If an alternative is not available, assess the risks and benefits of using the pump for each patient. Be aware of the MHRA’s advice on GemStar infusers in MDA/2013/078. Report any adverse incidents involving these pumps to the MHRA. Action by: All medical, nursing and technical staff involved in the use of these pumps.

Device

GemStar infusion system
  • Modelo / Serial
  • Descripción del producto
    Infusion pumps: GemStar infusion system. List numbers: 13000, 13100, 13150. The list numbers can be found on the rear of the device.
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    MHRA