Events

Alerte Ou Avis De Sécurité sur Alaris® GP volumetric pump

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/2013/017
  • Numéro de l'événement
    CON254808
  • Date
    2013-03-26
  • Date de publication de l'événement
    2013-03-26
  • 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/CON254808?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. the pump produces small air bubbles (less than 50μl) which are too small to trigger either the 50-500μl air-in-line alarm set by the user, or the 1ml over a rolling 15 minutes alarm.
  • Action
    Identify affected devices. Ensure members of staff are aware of the advice detailed in the manufacturer’s Field Safety Notice. In particular, CareFusion recommends the use of an air venting filter on the infusion set for the following patient groups: patients with atrial septal defects* neonates where multiple infusions are being administered simultaneously. Where a filter cannot be used, consider using an anti-siphon valve on the infusion set. Be aware of additional advice issued by CareFusion – see appendix. * up to 20% of the population may have patent foramen ovale, which may be undetected.

Device

Alaris® GP volumetric pump
  • Modèle / numéro de série
  • Description du dispositif
    Infusion pump: Alaris® GP volumetric pump Product refs: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G All serial numbers are affected.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion