Events

Alerta De Seguridad para HOMECHOICE FOR AUTOMATED PERITONEAL DIALISE. HOMECHOICE SYSTEM - VERSION 8.51

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
    679
  • Fecha
    2002-10-03
  • 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
    BRAZIL - 29.10.2002 - The automated Peritoneal Dialysis System for Homechoice and Homechoice PRO is registered in Brazil under the number 10068390123. According to company information (letter dated September 27, 2002), there are no reports of physical damage associated with this situation. Baxter is sending important information to be observed with the Homechoice System, software version 8.51, launched in June 2002 to notify the clinical and patient staff of home-based DPA-directed actions to reduce the likelihood of a possible excessive infusion of volume , which could occur under certain conditions.
  • Causa
    "it was found that stopping or advancing a manual drainage during an infusion phase could result in excessive infusion of volume. therefore, if the patient requires manual drainage during the filling phase, it is important that drainage is performed without interruption, with purpose of preventing excessive volume infusion. these instructions apply only to versions 8.51 and 8.52 of the homechoice system software.
  • Acción
    Routing of safety information to customers about the Homechoice System. Proposal for corrective actions (BAXTER): - Send letters with information to affected patients and to coordinators DE Home Care; -Send revised instructions from the patient manual to Homechoice users, help reports, and an operator's manual. -Correct the possibility of excessive infusion of volume with the next version of the software. For further information please contact us on 0800 12 55 22, option 1.

Device

HOMECHOICE FOR AUTOMATED PERITONEAL DIALISE. HOMECHOICE SYSTEM - VERSION 8.51

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA