Events

Alerta De Seguridad O Notificaciones De Seguridad para Lifeshield Primary Plumset

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/2013/081R
  • Número del evento
    CON346681
  • Fecha
    2013-12-05
  • Fecha de publicación del evento
    2013-12-05
  • 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/CON346681?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 embolism and allergic reaction due to exposure to particulates and non-biocompatible materials, especially during administration of parenteral lipids. due to a manufacturing fault, these devices may be fitted with an incorrect filter which has not undergone biocompatibility testing. hospira issued a field safety notice (fsn) dated 22 october 2013, but has not received confirmation from enough users that they have received and acted on this information.
  • Acción
    Identify, quarantine and do not use affected product lots. Use alternatives until new product is available from Hospira. Liaise with Hospira for the collection of affected product. Complete and return the reply form to Hospira. Report any adverse incidents to Hospira and the MHRA.

Device

Lifeshield Primary Plumset
  • Modelo / Serial
  • Descripción del producto
    Intravenous pump set: Lifeshield Primary Plumset. Specific list numbers and lot numbers are affected. List number Lot numbers Set description 14000-92-28 27112-5H 30079-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Prepierced Y-site, 272 cm 14001-92-38* 28187-5H Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Clave port, Clave Y-site, 272 cm *the equivalent NHS Supply Chain code for this list number is FSB1314 (England only). NHS Supply Chain has sent its own customer notice about this recall (reference NHS SC 32).
  • Manufacturer
    Hospira

Manufacturer

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