Events

Notificaciones De Seguridad De Campo acerca de Siemens BCS / BCS XP 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 Siemens Healthcare Diagnostics Products 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
  • 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
    Siemens healthcare diagnostics has observed that in very rare cases false short clotting times for pt on bcs and bcs xp with dade innovin can occur. this has also an effect for false high pt % of the norm or false low pt inr values. these false short clotting times were observed with turbid, hemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these rare samples showed a pre- peak, which can lead to falsely short clotting time. in rare cases the result was not flagged by the existing check algorithms. an example is given in figure 1. (left: expected reaction curve; right: erroneous evaluated reaction curve). .

Device

Siemens BCS / BCS XP System
  • Modelo / Serial
    BCS 10454728 (BCS RECONDITIONED) 10454729 (BCS RECONDITIONED) 10454742 (BEHRING COAGULATION SYSTEM) 10459303 (BCS RECONDITIONED) 10460659 (BCS INSTRUMENT) 10461881 (BCS INSTRUMENT) BCS XP 10459330 (BCS XP SYSTEM, COMPLETE) 10462449 (BCS XP ANALYZER SYSTEM) 10461894 (BCS XP) 10470625 (BCS XP REFURBISHED) Dade Innovin 10284500 10445704 10445705 10445706 10465673 10465674
  • Manufacturer
    Siemens Healthcare Diagnostics Products GmbH.

Manufacturer

Siemens Healthcare Diagnostics Products GmbH.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS