Events

Alerta De Seguridad O Notificaciones De Seguridad para GemStar docking station for use with specific GemStar infusion pumps

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/2013/085
  • Número del evento
    CON355511
  • 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/CON355511?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
    Potential for a delay in infusion therapy. two problems exist: when the docking station is used in conjunction with a gemstar phase 3 infusion pump, the pump may fail to power up when the gemstar phase 4 infusion pump is used in conjunction with both a docking station and an external battery accessory, this configuration could generate an error code 11/003, which could stop a running infusion. the manufacturer issued a field safety notice (fsn) dated 24 october 2013 but has not received sufficient confirmation that it has been received and acted upon.
  • Acción
    Identify affected devices/device combinations. Use an alternative pump, where available. Be aware of the recommendations in MDA/2013/078. If an alternative is not available: assess the risks and benefits of using these pumps for each individual patient ensure that staff are aware of all the issues and actions to be taken as specified in the manufacturer’s Field Safety Notice exercise caution in use report any adverse incidents involving these devices to the MHRA. fill in and return the reply form to Hospira.

Device

GemStar docking station for use with specific GemStar infusion pumps
  • Modelo / Serial
  • Descripción del producto
    GemStar docking station for use with specific GemStar infusion pumps. The specific products potentially affected by the two problems are shown below: Affected product (docking station list numbers) Issue Potential to occur in conjunction with products 13075-XX-07 13075-XX-09 Pump fails to power up Gemstar phase 3 pump (13000-XX, 13100-XX, 13150-XX) Error code 11/003 on pump and infusion stops Gemstar phase 4 pump (13086-XX, 13087-XX, 13088-XX) External battery pack (13073-XX) If you are unsure whether the Gemstar infusion pump is a phase 3 or a phase 4 contact Hospira for clarification. There is no corrective action in place to resolve this issue. Hospira is offering the Sapphire pump, manufactured by Q Care, on a part exchange basis to replace Gemstar pumps as detailed in Medical Device Alert MDA/2013/078 .
  • Manufacturer
    Hospira

Manufacturer

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