Events

Alerta De Seguridad para Product: SPECTRA OPTIA AFERESE SYSTEM. Model: AFERESE SPECTRA OPTIA SYSTEM. Anvisa Registration n ° 80554210002.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Terumo BCT Tecnologia Médica Ltda; TERUMO BCT 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
    1788
  • Fecha
    2016-01-12
  • 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 company, this possible error does not present risk to the functionality of the equipment. The error may occur in the following circumstances: (1) The user accidentally changes the weight and height values ​​when entering data into the Spectra Optia System; (2) The patient is weighed and measured in units that are different from those selected by the user in the equipment; (3) The user includes inaccurate height and weight data; (4) Abnormal calculation of the patient's total blood volume that may affect the outcome of the procedure.
  • Causa
    Alert on possible error in inclusion of user data records of patient weight and height in the spectra optia system, which would result in the abnormal calculation of the patient's total blood volume.
  • Acción
    This is a safety alert from the company about the correct inclusion of information in the Spectra Optia system. Users should verify the correct entry of information relevant to the safety of the procedure. The TerumoBCT clinical experts were instructed to advise users to double-check the patient's weight and height prior to the start of the procedure. Company code for field action: FA 24

Device

Product: SPECTRA OPTIA AFERESE SYSTEM. Model: AFERESE SPECTRA OPTIA SYSTEM. Anvisa Registration n...

Manufacturer

Terumo BCT Tecnologia Médica Ltda; TERUMO BCT INC