Alerta De Seguridad para Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por HORIBA ABX SAS.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-07-11
  • Fecha de publicación del evento
    2017-07-11
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: horiba abx sas yumizen h500 ct (closed tube) (version 2.1.0 or lower) the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning yumizen h500 ct (closed tube) (version 2.1.0 or lower), manufactured by horiba abx sas. product development activities by the manufacturer have shown that a defective positioning of the sampling needle could, in some instances, lead to a wear of the rinsing header ring of the needle. this technical issue could generate an over estimation of platelet counting. this background is usually detected when a blank cycle is performed at instrument start up (failed start up alarm). however, in other cases, the blank cycle does not detect the potential abnormal platelet background and could generate erroneous value of platelet counting. the potential overestimation of the platelet counting value could be critical for patients with thrombocytopenia and notably with severe thrombocytopenia which could then not be detected as severe. a corrective action has been identified by the manufacturer which consists of: new sampling needle adjustment needle ring replacement the manufacturer’s technician will implement the corrective action on affected yumizen h500 ct analyzer. while waiting for the corrective action, the manufacturer recommends the following solution for the patient samples with low platelet value suspicion: perform a blank cycle if blank cycle failed, re-run blank cycle if blank cycle passed, re-run their patient sample compare the 2 sample run values and repeat the procedure in case of significant discrepancy. for details, please refer to the mhra’s website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-3-to-7-july-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 july 2017.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HORIBA ABX SAS Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)
  • Manufacturer

Manufacturer