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 Healthcare.

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 021 03 17 001
  • Date de mise en oeuvre de l'événement
    2017-07-08
  • 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=11260
  • 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
    Baxter ag is initiating a field action in order to update software versions of the prismaflex control unit. baxter has received reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. unloading of the disposable set without following the instructions and warnings on the prismaflex control units may lead to severe blood loss and potentially fatal outcomes. since 2012, baxter has received reports of six serious injuries and five patient deaths associated with this issue.

Device

Prismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row and Prismaflex 7.XX ...
  • Modèle / numéro de série
    Product Codes: 107493, 113082, 113874, 114489 and 114870. Serial Numbers: All
  • Description du dispositif
    Continuous Renal Replacement Therapy (CRRT)
  • Manufacturer
    Baxter Healthcare

Manufacturer

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