Events

Alerta De Seguridad para IMMULITE 2000 and IMMULITE 2000XPI System, SIEMENS Brand, Risk Class I, records: 10345160645 and 10345161777, serial numbers: SEE ANNEX.

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

¿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
    1607
  • Fecha
    2015-06-09
  • 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 record holder when the problem is present the system will stop the sample processing. Siemens Healthcare Diagnostics has verified that the reagents do not freeze when the faulty PCB assembly is installed in the reagent carousel. Tests show that the temperature of the liquid reagent can be below 4 ° C, in which case they do not remain at temperatures low enough to freeze. Therefore there is no impairment of the reagents and the performance of the assay is not affected.
  • Causa
    The equipment may have been mounted with a faulty printed circuit board (pcb) sensor or its original sensor has been replaced with a faulty one. a specific set of temperature sensor boards has been improperly manufactured and may lead to ice formation causing mechanical obstruction and consequently interruption in sample processing.
  • Acción
    In the event of any error described below, contact your technical support representative to inspect the Siemens / IMMULITE 2000 XPi IMMULITE 2000 system: a. Error message [465] Reagent Carousel has jammed: • Occurs while the instrument is processing samples • Occurs when a mechanical jam is detected • Occurs when the device software fails to switch from STOP mode to RUN //// b. Error message [302] Reagent Carousel has jammed: • Occurs when device software does not boot from Desktop The Siemens technical support representative will inspect the product at the next technical visit to verify that the temperature sensor boards are faulty and will replace them if necessary.

Device

IMMULITE 2000 and IMMULITE 2000XPI System, SIEMENS Brand, Risk Class I, records: 10345160645 and ...

Manufacturer

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