Events

Alerte Ou Avis De Sécurité sur Alaris® SmartSite® needle-free valve

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 CareFusion.

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/2014/017
  • Numéro de l'événement
    CON418455
  • Date
    2014-05-21
  • Date de publication de l'événement
    2014-05-21
  • 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/CON418455?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 disconnection or inability to disconnect from the smartsite could result in delay to treatment due to: air entering the fluid path replacement of a central catheter or picc under-delivery and leakage of medication. carefusion issued a field safety notice (fsn) in february 2014 providing advice on this problem.
  • Action
    Quarantine affected lot numbers of SmartSite as listed in the Field Safety Notice. Follow instructions in the FSN including returning verification form to CareFusion. Ensure all users are aware of manufacturer’s Field Safety Notice Arrange for replacement devices.

Device

Alaris® SmartSite® needle-free valve
  • Modèle / numéro de série
  • Description du dispositif
    Alaris® SmartSite® needle-free valve Product reference: 2000E7D Specific lot numbers The Smartsite is a needle-free IV access device. Affected devices are made from a polycarbonate material. The affected lot numbers are: 13086202, 13086263, 13086309, 13095185, 13095913, 13095914, 13096487, 13096488, 13096489, 13105366, 13105478, 13106563, 13106710, 13106711, 13115316. If relevant to you, the national supply codes are as follows: England NPC: FSW165 Scotland SKU: 066032 Northern Ireland BSO: does not have a PALS reference number Wales NSV: FSN342 Only product code 2000E7D is affected and other configurations or item numbers are not affected. This Medical Device Alert does not affect CareFusion’s MaxPlus or MaxZero needle-free connectors.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion