Events

Alerta De Seguridad para SPECTRA OPTIA AFERLEAN SYSTEM. Anvisa registry n ° 80554210002. Affected units existing in Brazil: 1PO01174, 1PO01177, 1PO00997 and 1PO00999. Affected software version: 5 and later.

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 INC; CaridiaBCT Tecnologia Médica Ltda.

¿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
    1143
  • Fecha
    2012-06-18
  • 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
    The problem affects the air sensor of the equipment, resulting in a continuous alert and interruption of the procedure. Stopping the procedure during collection of mononuclear cells may result in reworking the procedure. According to the registry holder, the residual risk of air being returned to the patient is low when using the equipment as indicated, even with the existence of the problem mentioned.
  • Causa
    Problem in the air detection sensor.
  • Acción
    Identify affected products in your inventory. Provide a reserve apheresis system or draw up a contingency plan in order to prevent any equipment failure during use. Please pass the information in this alert to all users of the product. The company CaridianBCT Ltda has indicated that it intends to finalize the correction of the problem (through software update) until August 2012.

Device

SPECTRA OPTIA AFERLEAN SYSTEM. Anvisa registry n ° 80554210002. Affected units existing in Brazil...

Manufacturer

TERUMO BCT INC; CaridiaBCT Tecnologia Médica Ltda
  • Source
    ANVSANVISA