Events

Alerte Ou Avis De Sécurité sur Lifeshield Primary Plumset

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Hospira.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/081R
  • Numéro de l'événement
    CON346681
  • Date
    2013-12-05
  • Date de publication de l'événement
    2013-12-05
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON346681?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA