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 Terumo BCT Inc..

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 056 12 18 000
  • Date de mise en oeuvre de l'événement
    2018-12-16
  • 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=13621
  • 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
    This letter provides information about the new iv pole collar accessory for the trima accel system. new trima accel systems will be shipped with an iv pole collar (see figure 1 in the attached fsn). this feature has been added to avoid a pinch point between the iv pole cross bar and the machine while lowering the iv pole. on new machines, the service technicians will attach the iv pole collar to the iv pole during installation. if the operator does not hold onto the iv pole while pressing the iv pole release button, the iv pole may drop in a free fall. if the operator’s hand or any other body part is in the path of the free-falling iv pole, the operator could be injured. because this is an added safety feature, do not remove the collars after they are installed on the iv pole.

Device

Trima Accel® Automated Blood Collection System
  • Modèle / numéro de série
    Trima Accel® Automated Blood Collection System
  • Description du dispositif
    Apheresis Units, Blood Donor
  • Manufacturer
    Terumo BCT Inc.

Manufacturer

Terumo BCT Inc.
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Représentant du fabricant
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA