Events

Alerta De Seguridad para HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER. Anvisa Record: 10068390123. All the serial numbers.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Hospitalar 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
    1009
  • Fecha
    2010-03-16
  • 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 company said it is already developing changes in the instruction manual and product software to reduce the potential incidence of AVIP due to user or user misuse. For more details, see the annexes to this alert: http://portal.anvisa.gov.br/wps/wcm/connect/a5665b8041c553a39e9cdf255d42da10/Carta+ao+cliente.pdf?MOD=AJPERES and http: //portal.anvisa .gov.br / wps / wcm / connect / 3ec16a8041c554959eacdf255d42da10 / Annex + about + AVIP.pdf? MOD = AJPERES. Anvisa's Technovigilance Unit is monitoring this case.
  • Causa
    Risk of occurrence of intraperitoneal volume increase (avip), associated with the use of the homechoice cycler.
  • Acción
    Clinicians should carefully schedule infusion volumes for each patient to avoid AVIP. Drainage alarms and ultrafiltration percentages should be programmed to ensure sufficient patient drainage - insufficient drainage can lead to an AVIP situation.

Device

HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER. Anvisa Record: 10068390123. All the serial numbers.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA