Alerte De Sécurité sur Alaris syringe pumps (all models)

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par CareFusion.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-12-23
  • Date de publication de l'événement
    2016-12-23
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: alaris syringe pumps the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning alaris syringe pumps (all models). alaris syringe pumps are manufactured by carefusion – using non-recommended syringes in alaris syringe pumps that have a broken spring in the plunger assembly may cause unintended bolus of medication. users are advised to: if the pump keeps showing ‘check syringe’ alarms, contact the manufacturer to discuss how to check the springs housed in the plunger holder; use only the recommended syringes listed in the instructions for use for these pumps; ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s recommendations. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/alaris-syringe-pumps-all-models-risk-of-uncontrolled-bolus-of-medicine-with-non-recommended-syringes if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2016.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Alaris Syringe Pumps
  • Manufacturer

Manufacturer