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 080 03 14 000
  • Date de mise en oeuvre de l'événement
    2014-03-18
  • 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=5492
  • 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 healthcare is implementing additional warning label. specific population using peritoneal dialysis therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. the additional warning identifies symptoms related to unintended increased intraperitoneal volume (iipv) that may result in theses specific populations and provides specific instructions for the patient to follow if increased intraperitoneal volume (iipv) that is suspected.

Device

HomeChoice Automated Peritoneal Dialysis Systems, HomeChoice PRO Automated Peritoneal Dialysis Sy...
  • Modèle / numéro de série
    Product Nos.: 5C4471, 5C4471R, 5C8310, 5C8320, 5C8310R
  • Description du dispositif
    Peritoneal Dialysis Units
  • 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