Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Radiometer Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 165 07 13 002
  • Fecha de inicio del evento
    2015-04-29
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=7560
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    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
  • Modelo / Serial
    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
  • Descripción del producto
    Pco2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Representante del fabricante
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA