Alerta De Seguridad para Machine for hemodialysis, Baxter brand, model SYSTEM 1000, TINA, ANVISA registration no. 10068390356.

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

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The Unit of Technovigilância - UTVIG / NUVIG / ANVISA is following the actions of the company according to voluntary notification of Baxter Hospitalar Ltda.
  • Causa
    Baxter has discovered the potential possibility that fluid or air passing through the venous line clamp can result in gas embolism. this condition may occur when the tubing is not centered in the clamp and extends beyond the edge of the clamping zone of the clamp (see figures 1 and 2 for correct piping positions). when reviewing the history of complaints of this type of product problem, 10 events were identified with the same failure mode, but could not be directly associated with this problem. figure 1: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2006/831_figura1.Jpg figure 2: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2006/831_figura2.Jpg.
  • Acción
    Baxter will provide means of upgrading your equipment by updating the linear or rotating line clamp. Until such updates are available, the company recommends not to withdraw the operating equipment as it is designed to automatically issue an alarm, trigger the line clamp, and interrupt the blood pump if air is detected on the line. However, until the upgrade or temporary adjustment of the line linear clamp is performed, it is FUNDAMENTAL to make sure that the piping is in the center of the clamping zone and to observe any extracorporeal or air detection alarms to ensure that the clamp properly blocking the tubing. If extracorporeal or airway alarms are activated, the following steps should be followed: 1. Manually pinch the venous line between the venous line clamp and the patient, near the vascular access. Use the clamp on the vascular line or a hemostatic forceps; 2. Turn off the blood pump; 3. Use the "up" venous level adjustment knob to reduce venous pressure near zero; 4. Carefully inspect the venous line above and below the venous line clamp for air or micro bubbles; 5. Refer to the relevant sections in the SYSTEM 1000, TINA Operating Manuals that specifically address the recovery of the Air Detection Alarm. If you have any questions about the release, call Baxter Technical Service 0800-125522, Option 3.


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