Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Baxter Corp Canada.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 054 06 17 000
  • Date de mise en oeuvre de l'événement
    2017-06-15
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11184
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    After a planned sharesource outage on may 28, 2017, three issues occurred: - the patient consent to share data was required, even though there was no revision of the patient consent content. a failure to submit a patient consent through the claria cycler resulted in patients being prompted to enter the patient activation code (pac) before each treatment, and no treatment data from the claria is shared with the clinic. - clinicians saw incorrect message “not for human use” on sharesource website. - some reviewed treatment history was not visible; those treatments were no longer marked as “reviewed”.

Device

Sharesource Claria Connectivity Platform for Use with Homechoice Claria APD System
  • Modèle / numéro de série
    Product Code# 5CGM01
  • Description du dispositif
    home dialysis therapy
  • Manufacturer
    Baxter Corp Canada

Manufacturer

Baxter Corp Canada
  • Société-mère du fabricant (2017)
    Baxter International
  • Représentant du fabricant
    Arabian Health Care Supply Co. (AHCSC) Riyadh (01) 4747444
  • Source
    SFDA