Events

Alerte Ou Avis De Sécurité sur Haemofiltration machine

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 Baxter.

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
    2017-07-11
  • Date de publication de l'événement
    2017-07-11
  • 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/haemofiltration-machine-all-prismaflex-systems-installed-with-software-version-6-10-risk-of-under-infusion-of-anticoagulant
  • 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 baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
  • Action
    Identify affected devices. Ensure that: users understand the problem detailed in the Field Safety Notice and follow the manufacturer’s advice Have systems in place to ensure the upgrade is undertaken as soon as possible or at least by the next planned annual maintenance service. Baxter will contact users to schedule the software upgrade of your devices to rectify the issue. Return the Field Safety Notice acknowledgement form to Baxter as currently the manufacturer hasn’t received enough responses.

Device

Haemofiltration machine
  • Modèle / numéro de série
  • Manufacturer
    Baxter

Manufacturer

Baxter
  • Adresse du fabricant
    Pranil Patil Team Lead CQA Baxter Healthcare Ltd.Telephone: 01604 704 603uk_shs_fca@baxter.com
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    MHRA