Alerta De Seguridad para Cardiac Debit Monitor, Vigilance brand, models with software version 5.3 or earlier, ANVISA registration no. 80219050079 manufactured before March 2003.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Edwards Lifesciences CO..

¿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
    839
  • Fecha
    2006-09-26
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Since the introduction of the DCC catheter in 1993, Edwards in the US has been informed of two events in that country in more than 2 million users where the monitor generated enough energy to cause extensive heat damage to the DCC catheter. Both events occurred in the absence of flow. In one of the events, there was damage to the patient in myocardial revascularization surgery; on the other, there was no harm. This risk does not apply to all Vigilance Monitors. This software version is only found on Edwards Monitors distributed before March 2003. Vigilance monitors with software version 5.4 and later are not affected. Vigilance Monitors with CEDV, Vigilance II and Vigileo are not affected. In Brazil, Edwards Lifesciences CIPMC Ltda started the "recollection" of the monitors in July 2006 for the update. All customers are being contacted. In the links, there is the Letter from the Manufacturer http://www.anvisa.gov.br/tecnovigilancia/alertas/alerta_839_carta_recall_monitores_vigilance_edwards.pdf and the serial numbers of the affected products http://www.anvisa.gov.br/tecnovigilancia . *** Update 17/10/2006 ***************************** The Company informs that the software update for all products affected.
  • Causa
    Edwards has identified that vigilance monitors with software version 5.3 or earlier may cause inadequate release of energy to the continuous cardiac output (dcc) catheter without alerting the user to this situation. this can result in overheating and thermal damage to the dcc catheter and serious damage to the patient.
  • Acción
    Edwards Lifesciences started product recall and is contacting all customers who have version 5.3 or earlier monitors to upgrade these monitors to the approved version (5.4).

Manufacturer

  • Source
    ANVSANVISA