Alerta De Seguridad para Trade name: Exactrac Location System. Technical Name: Stereotaxic System. ANVISA registration number: 80042070004. Class of risk: III. Affected Model:. Serial number affected: 8596415001; 202616001; 202616001

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Brainlab Ltda; Brainlab AG.

¿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
    2497
  • Fecha
    2018-02-27
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    Always follow the instructions specified in the Field Safety / Product Notification Notice when using the ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 11/21/2017 - Date of notification notice for Anvisa: 02/16/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    One patient was being positioned for a prostate radiotherapy treatment with the brainlab exactrac positioning system and the varian truebeam radiotherapy system using the auxiliary device interface (adi). for this specific treatment, the patient was opened on varian's truebeam and a message box to open the same patient was shown on the exactrac. the treatment field was selected and prepared in truebeam and only after the message box to open the patient was accepted in exactrac, by clicking the "open" button, which automatically opened the patient in the exactrac software. after the pre-positioning of the patient the correction changes to the exact position of the patient was calculated by the exactrac through the x-ray correction. corrections could not be applied to the treatment table and exactrac showed a corresponding error message. apparently, although the fixes were not applied and exactrac did not show the "ok" icon, truebeam was authorized to treat and the treatment was started by the hospital technologist. after a few seconds of treatment, the hospital technologist realized that the exactrac software did not show "ok" for the correct positioning of the patient and he stopped the treatment.
  • Acción
    Field Action Code CAPA-20180124-002060 triggered under the responsibility of the company. Brainlab Ltda. Update of the instructions for use.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA