Events

Alerta De Seguridad para Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; 251626; 290672W; 161762. /// Product 2. BCS XP SYSTEM, registry 10345161642, risk class I, batches affected: 311502; 280727; 280800; 301266; 301267; 280775; 221651; 331848; 442036.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH.

¿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
  • ID del evento
    1595
  • Fecha
    2015-05-21
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    According to the manufacturer the health risk is related to the possibility of inappropriate classification, for higher values, of Factor IX, for results of patients in the lower reading range. It is important to know that hemophilia B is characterized by the deficiency of Factor IX coagulation activity that results in prolongation of bleeding after injury, dental extractions or surgeries, and recurrent delay or bleeding before complete wound healing.
  • Causa
    Release of erroneously high results for factor ix with the application protocols of the bcs and bcs xp systems at the lower limit of the measurement range.
  • Acción
    The registry holder will change protocols for the implementation of the Factor IX Define test. In addition, it is advised to discontinue use of the "Factor IX with Pathromtin SL [34]" application protocol and instead use the "Factor IX with Pathromtin SL [463]" application protocol; discontinue the use of extrapolation for reading values ​​at lower levels of the "Factor IX with Pathromtin SL [463]" application protocol and "Factor IX with Actin [467]" application protocol. Do not report patient results below 30% F IX for application protocols "Factor IX with Actin FSL [471]".

Device

Product 1. BCS SYSTEM, registration 10345161639, risk class I, batches affected: 321208; 361922; ...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA