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 Lundia AB.

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 039 11 16 000
  • Date de mise en oeuvre de l'événement
    2016-11-06
  • 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=10188
  • 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 ag is issuing a voluntary urgent device correction for ak 98 dialysis machines due to two software issues. : i. the machine could become stuck in a fluid by-pass state if the operator confirms the air detector alarm during priming. in a fluid bypass state, the fluid path bypasses the dialyzer and no ultrafiltration (uf) or diffusion occurs, leading to an absence of treatment. ii. the ultrafiltration supervision (ufs) may be put in an idle (non-functional) state, if the functional check of the blood module is delayed and is completed after the functional check of the fluid module.

Device

AK 98, 230V, Bio
  • Modèle / numéro de série
    Product Name: AK 98, 230V, Bio Product Code: 115248 Serial Numbers: All (please refer to attached affected customers list).
  • Description du dispositif
    Dialysis machine
  • Manufacturer
    Gambro Lundia AB

Manufacturer

Gambro Lundia AB