Events

Alerta De Seguridad para HomeChoice Automated Peritoneal Dialysis System

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
    801
  • Fecha
    2005-12-03
  • 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
    Although the possibility of this type of event occurring is remote, it presents potential risk due to the shock. If you find it difficult to turn the machine on or off, or if you notice that the power switch is loose, immediately unplug the machine and contact the technical service by calling 0800-125522 option 3 for orientation. According to Company information, no similar occurrence was reported by its customers in Brazil. The UTVIG / ANVISA - Tecnovigilância Unit will be following the entire process of updating the HomeChoice machines until the moment of its closure.
  • Causa
    Reports from patients who received electric shock using homechoice. investigation conducted through the company baxter healthcare corporation, route 120 & wilson road, round lake, 60073-0490, confirmed that the homechoice machine's on / off switch pin loosened, causing a circuit breaker. this key is not grounded.
  • Acción
    All HomeChoice machines are being upgraded with on-off switches. All new and refurbished machines, manufactured after August 1, 2004, have a grounded on / off switch.

Device

HomeChoice Automated Peritoneal Dialysis System

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA