Events

Notificaciones De Seguridad De Campo acerca de ROTEM® delta Thromboelastometry System

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Tem Innovations GmbH.

¿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
    Field Safety Notice
  • Fecha
    2017-03-14
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Internal and external observations with some vials of r ex-tem, lot 21734044 (expiration 10/2017) demonstrated prolonged ct values. in testing, some whole blood patient samples have shown ct values up to 4 times longer than expected. qc measurements with rotrol n or p have also produced longer ct’s as compared to other lots; these ct values have at times exceeded the target ranges. all other parameters and functions such as heparin neutralization or sensitivity to factor deficiencies remain unaffected. while the root cause of these observations is currently under investigation, we have taken the decision to recall this lot. .

Device

ROTEM® delta Thromboelastometry System

Manufacturer

Tem Innovations GmbH