Events

Alerta De Seguridad para Faucet 3 ways Descarpack - Registration 10330669026 - Affected lot TV0164.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Descarpack Descartaveis do Brasil 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
    1153
  • Fecha
    2012-07-23
  • 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
    Due to the patient being in use of vasoactive drugs, the leakage of the 3-way Faucet causes a smaller amount of medication administered, which in this case may result in hemodynamic instability in the patient. To reverse the condition, it would be necessary to increase the amount of vasoactive drugs administered. # UPDATED ON 7/8/2012: REPLACEMENT OF THE BATCH NUMBER. THIS IS THE LOT TV0164 ##### CLOSED ####
  • Causa
    The 3-way tap presented medication leakage, through its central part, in a postoperative patient of aortic valve replacement surgery.
  • Acción
    It is recommended that the health care team check the 3-way Faucet for possible leakage of solutions through the central portion of the same. Extravasation, when it occurs, can be easily visualized. Avoid use; segregate the material in your inventory and communicate to the supplier for collection and exchange.

Device

Faucet 3 ways Descarpack - Registration 10330669026 - Affected lot TV0164.

Manufacturer

Descarpack Descartaveis do Brasil Ltda.