Events

Alerta De Seguridad O Notificaciones De Seguridad para 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
  • Número del evento
    MDA/2013/004
  • Fecha
    2013-02-06
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/medical-device-alert-infusion-pumps-plum-a-single-channel-infuser-systems-risk-of-interruption-in-therapy
  • 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
    Risk of interruption in therapy due to clinical staff failing to hear the alarm.The operation of the alarm volume control is not consistent with the operator’s manual. On some pumps, the knob is turned clockwise to increase the volume, on others, it is anticlockwise.Hospira will be updating the user manual and providing labels for each device to identify the correct operating direction.
  • Causa
    (hospira) clinical staff failing to hear an audible alarm. (mda/2013/004).
  • Acción
    Ensure members of staff are aware that the alarm volume level control is not the same on all these pumps. Ensure that relevant members of staff are familiar with the steps to check the alarm as described in the manufacturer’s Field Safety Notice (dated 29 October 2012), in particular the need to confirm the volume level before beginning therapy. Contact Hospira to arrange for volume direction labels to be fixed to all devices. If you have more than one device being used in the same location and they do not have the same alarm volume control, you may contact Hospira for adjustment of the direction of the volume control to ensure consistency.

Device

Infusion pumps
  • Modelo / Serial
  • Descripción del producto
    Infusion pumps: Plum A+ single channel infuser systems.Manufactured by Hospira.Product codes: 11005, 11971, 12391, 20792.The following single channel infuser systems are affected by this alert:Plum A+ hyperbaric infusion system. Affected product code: 11005 Plum A+ single channel infusion system. Affected product codes: 11971 + 12391 Plum A+ infusion pump. Affected product code: 20792.
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Dirección del fabricante
    John McIlvaney Customer Services Manager Hospira UK Queensway Royal Leamington Spa CV31 3RW Tel: 0800 028 7304 Fax: 0800 028 7305Email: custserv@hospira.com
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    MHRA