Events

Alerta De Seguridad para HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER .. REG. ANVISA: 10068390123.

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
    899
  • Fecha
    2008-01-24
  • 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
    Attached to the communication letter to be sent by Baxter Ltda to its customers, will follow a response form that must be completed as soon as possible and sent to the company. ### The company announces the closure of the field action of updating the software of the machines through the file 824688 / 09-2, 10/29/2009.
  • Causa
    During a filling cycle, if the system is shut down or power failure occurs, the homechoice system may not register up to the last four pump drives infused into the patient when the power is reestablished. such a situation may lead to unregistered application of 15 to 60 ml of the fluid being infused into the patient.
  • Acción
    The company Baxter Hospitalar Ltda will be providing an updated version of the equipment software and has already begun to contact its customers through communication letters. The Technovigilance Unit is following the case.

Device

HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER .. REG. ANVISA: 10068390123.

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA