Alerta De Seguridad para CELLEX Photopheresis System

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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: therakos, inc. cellex photopheresis system the united states food and drug administration (fda) issued a letter to the health care providers regarding recent reports of venous thromboembolism (vte), including pulmonary embolism (pe), in patients who received autologous immune cell therapy with the cellex photopheresis system, manufactured by therakos, inc. the cellex photopheresis system is an extracorporeal photopheresis (ecp) device system using ultraviolet-a irradiation of extracorporeally circulating leukocyte-enriched blood for the palliative treatment of the skin manifestations of cutaneous t-cell lymphoma that is unresponsive to other forms of treatment. since 2012, the fda has received seven reports of patients experiencing pe during, or soon after, active treatment sessions (mean 1.2 days). two of these reports were associated with the death of the patient, although the link between the pe and death cannot be made with certainty. of the seven pe events, four occurred in patients known to be undergoing treatment for graft-versus-host disease (gvhd), including the two patients who died. in addition to pe, the fda has received two reports noting the diagnosis of a deep vein thrombosis (dvt) in an extremity of a patient during, or soon after, an ecp session. both of these occurred in patients undergoing treatment for gvhd. although allogeneic transplant patients who develop gvhd are known to be at increased risk for vte, the timing of the events in these reports suggests that ecp therapy may increase that risk. the fda recommends health care providers: alert patients, and clinical staff and technicians involved in ecp procedures, to the signs and symptoms of pe and dvt that can develop during or after a procedure. refer to device labeling regarding considerations for anticoagulation use with this system and use clinical judgment in adjusting an individual patient's heparin dosage. report vte events related to ecp procedures that come to their attention. for details, please refer to the fda websites: https://www.Fda.Gov/medicaldevices/safety/letterstohealthcareproviders/ucm595147.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm595476.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Therakos, Inc. CELLEX Photopheresis System
  • Manufacturer