Events

Alerte Ou Avis De Sécurité sur All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps

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/BD Medical.

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
  • Date
    2017-04-12
  • Date de publication de l'événement
    2017-04-12
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/all-alaris-gs-gh-cc-tiva-pk-enteral-syringe-pumps-and-asena-gs-gh-cc-tiva-pk-syringe-pumps-risk-of-uncontrolled-bolus-of-medicine
  • 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
    Manufactured by carefusion/bd medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps.
  • Action
    Identify all devices with the product codes listed in the FSN Ensure hospital or Carefusion service specialist checks pumps as detailed in the FSN Prioritise devices used in paediatric/neonatal/critical care areas and all devices more than three years old Ensure hospital or CareFusion replace broken springs Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s updated preventative maintenance Note that this alert replaces MDA/2017/003, which we published in February 2017

Device

All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syring...
  • Modèle / numéro de série
  • Description du dispositif
    Product Name: Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005, 8007Product Name: Asena™ GS, GH, CC, TIVA, PK Syringe Pumps Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005
  • Manufacturer
    CareFusion/BD Medical

Manufacturer

CareFusion/BD Medical
  • Adresse du fabricant
    CareFusionTel: 0800 917 8776Email: UK-customer-service@carefusion.com
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    MHRA