Events

Alerte Ou Avis De Sécurité sur Mains power lead used with Omnifuse syringe pumps (all models)

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 Smiths Medical International Ltd.

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/2014/044
  • Numéro de l'événement
    CON478823
  • Date
    2014-11-26
  • Date de publication de l'événement
    2014-11-26
  • 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/CON478823?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 interruption or delay in therapy due to incorrect design of the mains lead supplied by smiths medical. smiths medical ltd has issued a field safety notice (fsn), dated november 2014, to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information. the original fsn was sent in september 2014.  the manufacturer recently identified that more customers were affected and so has issued this second fsn. these 2 fsns provide the same information.
  • Action
    Ensure all personnel using these devices are aware of this FSN. Quarantine affected leads. Use an alternative pump, where available until a replacement lead is obtained. Fill in the confirmation form in the FSN and return it to the manufacturer by fax on 01582 430 001 or by  email to ukcs@smiths-medical.com

Device

Mains power lead used with Omnifuse syringe pumps (all models)
  • Modèle / numéro de série
  • Description du dispositif
    Mains power lead used with Omnifuse syringe pumps (all models). Part number 0151-0651.
  • Manufacturer
    Smiths Medical International Ltd

Manufacturer

Smiths Medical International Ltd