Events

Alerta De Seguridad para Hemodialysis machine model 1000, Anvisa registry nº 10068390356 and model SPS, registry Anvisa nº 10068390088.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Empresa Baxter Hospitar 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
    800
  • Fecha
    2005-01-27
  • 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
    Air in the blood line can cause gas embolism in hemodialysis patients. Issuance of letter to the clinicians responsible for the devices and hemodialysis therapy reporting of the corrective action to be performed in the manuals of the machine operator. If you have any questions, please contact Baxter technical support by calling 0800 12 55 22, option 3 or e-mail the national director of technical services, carmine_maglio@baxter.com. The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
  • Causa
    Reports of air bubbles were observed in the blood line, after the air detector, without sounding the alarm warning the operator of the possibility of air in the blood line.
  • Acción
    One review showed inadequate use, including failures in the practices commonly observed in hemodialysis. The company informs that it has updated Operator's Manuals and training guides to clarify the instructions and add caution and caution phrases to call attention to the possibility of air entering the extracorporeal circuit and to clarify methods for withdrawing air from the circuit.

Device

Hemodialysis machine model 1000, Anvisa registry nº 10068390356 and model SPS, registry Anvisa nº...

Manufacturer

Empresa Baxter Hospitar Ltda
  • Source
    ANVSANVISA