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 Codan Argus AG.

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 057 05 14 000
  • Date de mise en oeuvre de l'événement
    2014-05-13
  • 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=5&rid=5823
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    The basis of this field safety notice are pertaining to the frequent technical errors #8123 and #8129 on codan argus 717v infusion pumps. technical errors #8123 and #8129 originate from the self-test of the down-stream pressure sensor. analysis by the manufacturer revealed that apart from broken pressure sensors, excessive hardness of the intravenous infusion set could trigger these technical errors. the technical errors occur once the intravenous infusion set is inserted and the user closes the pump door - before the infusion is started. any such delay of infusion or interruption of therapy through a false infusion pump alarm, which may potentially put the patient’s health at risk, is unacceptable. unanticipated variations of the mechanical properties of the intravenous infusion sets were identified as the root cause of above mentioned false technical errors.

Device

Infusion pump CODAN ARGUS 717/718V
  • Modèle / numéro de série
    Control software version 5.05
  • Description du dispositif
    Infusion pump, multifunction
  • Manufacturer
    Codan Argus AG

Manufacturer

Codan Argus AG
  • Société-mère du fabricant (2017)
    Codan Argus Ag
  • Représentant du fabricant
    Al-Jeel Medical & Trading Co. LTD, Riyadh (011) 4041717
  • Source
    SFDA