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 Radiometer Medical.

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 165 07 13 002
  • Date de mise en oeuvre de l'événement
    2015-04-29
  • 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=7560
  • 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
    Radiometer has become aware that some d788 pco2 membranes can cause biased measurement results on patient results as well as qc results. the bias can be seen after the replacement of the membrane, and will be positive in the low range and negative in the high range. there is a risk of wrong diagnosis and maltreatment of patients for biased measurement results in the high range , root cause investigation is still in progress, but the preliminary root cause is variations in the thickness of a silicone layer used in the membrane units. the error was discovered through internal testing on blood and qc material in connection with a capa raised to document the investigation of an issue regarding low qc comparison results. ....................... bfarm update action: your local radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and abl800 series analyzers. the improved sealing ring may be identified by its blue color.

Device

Analyser, blood gas , pCO2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
  • Modèle / numéro de série
    R338 to R493; part 942-063, pCO2, D788 Membrane ............................ Update code from MHRA: Select one of the Quality Control products listed below to be used for pCO2 verification: Qualicheck3+: S7330 (Level 1) Autocheck3+: S7335 (Level 1) Please see the attachment
  • Description du dispositif
    Pco2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Représentant du fabricant
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA