Events

Alerta De Seguridad para Trade Name: HOMECHOICE FOR DIALISE PERITONEAL BAXTER; Model: 5C4471; record 10068390123, risk class III

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; Baxter Healthcare SA.

¿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
    1853
  • Fecha
    2016-02-29
  • 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 Baxter Hospitalar Ltda declares the cycler HomeChoice uses an air pump (pneumatic); some sounds related to the operation of the pump as a normal part of the operation of the HomeChoice cycler are expected. There will be sounds like buzzing, whistling, shaking, and ventilation (air release), which are normal during cycler operation. An increase in the level of sounds is expected at certain times of therapy, which is also part of normal operation. If there is a significant change in sound level or a new sound not previously heard during your time of use of HomeChoice, please contact your doctor and / or nurse or Baxter Technical Service.
  • Causa
    Baxter is globally executing a communication action with the ministries of health regarding the increased trend of noise-related reporting in homechoice equipment in the united states during the year 2015. noise, expected sounds related to pump operation as a normal part of the operation of the homechoice cycler, since it uses an air pump (pneumatic) during its operation. sounds such as buzzing, whistling, shaking, and ventilation (air release) are normal during cycler operation. an increase in the level of sounds is also expected at certain times of therapy, which is also part of normal operation. baxter, globally, has not received reports of adverse events or damage to patients related to this situation, as well as there is no expected adverse event resulting from the use of the equipment.
  • Acción
    Inclusion of Alert in the Operator's Manual. Action code FCA 2015-052

Device

Trade Name: HOMECHOICE FOR DIALISE PERITONEAL BAXTER; Model: 5C4471; record 10068390123, risk cla...

Manufacturer

Baxter Hospitalar Ltda; Baxter Healthcare SA