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 Gambro..

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 034 01 11 000
  • Date de mise en oeuvre de l'événement
    2011-01-17
  • 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=49
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    The patient / priming detector is integrated in the venous clamp. if the start up procedures for on-line priming described in the operator's manual are not followed when preparing the ak 200 ultras and ak 200 ultra machines for a patient treatment, a significant safety feature may be compromised, in which case the device may not be able to detect blood. this issue may arise if the operator: -fails to properly attach the venous line in the venous clamp during the priming procedure; and -fails to verify the illumination of the machine blood path indication after patient connection; and -fails to confirm start of treatment; and - ignores the audible alarm and attention related to the achieved extra priming volume.

Device

HAEMODIALYSIS SYSTEMS.
  • Modèle / numéro de série
    AK 200 ULTRA S with software 9.20 or older AK 200 ULTRA with software 8.00 or older
  • Description du dispositif
    HAEMODIALYSIS.
  • Manufacturer
    Gambro.

Manufacturer

Gambro.
  • Société-mère du fabricant (2017)
    Baxter International
  • Représentant du fabricant
    Arabian Medical Marketing Co. (AMCO), Riyadh, (01) (01) 4887122
  • Source
    SFDA