Events

Alerta De Seguridad para FLO-GARD VOLUMETRIC INFUSION PUMP. MODELS 6200, 6201, 6300 AND 6301 .. RISK CLASS III.

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
    881
  • Fecha
    2007-08-08
  • 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
    Baxter Hospital Ltda informs that the risks associated with absence of alarm when occlusion occurs above the flexible chamber of the infusion pump are: the return flow of the patient's blood, the loss of the infusion line or the non-administration of the drug to the patient. Still according to Baxter, the conditions that may potentially cause these situations are as follows: (1) when the vial or pouch has been emptied, but the pump continues to pump; (2) when the spike was not completely inserted into the bottle or pouch; (3) when a rigid bottle (glass bottle, for example) or semi-rigid bottle (Buretrol, for example) is improperly vented. In these cases, according to the addendum to the manual, specific prevention measures should be observed. Anvisa's Technovigilance Unit is monitoring this case.
  • Causa
    Infusion pump alarm may not work when occlusion occurs above the flexible chamber of the equipment.
  • Acción
    Baxter Hospitalar do Brasil Ltda has already located the customers involved and has forwarded to them an addendum to the equipment operation manual. This addendum informs about the possibility that the pump does not alarm when there is occlusion above the flexible chamber, defines the situations in which this problem may occur and indicates the additional precautions to be observed.

Device

FLO-GARD VOLUMETRIC INFUSION PUMP. MODELS 6200, 6201, 6300 AND 6301 .. RISK CLASS III.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA