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 022 05 18 000
  • Date de mise en oeuvre de l'événement
    2018-05-07
  • 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=12573
  • 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
    Terumo states that if a blood warmer is attached to the tubing set of the above apheresis systems and the blood warmer is not primed before use, air could be delivered to a patient. the firm is reinforcing actions required to mitigate this risk. terumo states that many spectra optia procedures include the option to use a blood warmer. the spectra optia operator's manual instructs operators how to connect and prime a blood warmer when one is used. the operator's manual also includes warnings about the risk of delivering air to a patient if a blood warmer is not primed. further details are provided in attached letter.

Device

Spectra Optia Apheresis Systems
  • Modèle / numéro de série
    Apheresis Systems Spectra Optia 61000
  • Description du dispositif
    Apheresis Units, Blood Donor, Plasma , Therapeutic, Platelet/Plasma Exchange , White Blood Cell
  • Manufacturer
    Terumo BCT Inc.

Manufacturer

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