Events

Alerta De Seguridad para MARS Treatment Kit, registration no. 80134860075.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TERAKLIN A G.

¿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
    838
  • Fecha
    2006-09-18
  • 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
    According to Gambro Rostock, no injuries were reported in patients, however, there is a possibility of indirect loss of body fluid from the patient, caused by loss of albumin in the waste from the dialysis process. Specifically, this may be the case when the customer sets the low pressure alarm setpoint to too low relative to the current pressure too low. Inquiries or clarifications, please contact the company responsible for the product: GRIFOLS DO BRASIL LTDA (41) 3668-2444.
  • Causa
    Possibility of ruptures in the pump segment within the mars albumin circuit.
  • Acción
    Material quality controls were implemented to avoid recurrence of this type of event. In addition, the tube manufacturing process was optimized in 2005, resulting in significantly higher and longer lasting stability of the pump segment. To exclude any remote risk to patient health, in the event of pump segment ruptures, Gambro Rostock instructs all customers that "To manually change the pressure alarm set point, make sure that the difference between the current pressure and the lower alarm set point does not exceed 100 mmHg. "

Device

MARS Treatment Kit, registration no. 80134860075.

Manufacturer

TERAKLIN A G
  • Source
    ANVSANVISA