Events

Alerta De Seguridad para ARIA Software (ARIA for Radiation Technology). Anvisa Registry No. 10405410013. Models at risk: V.10.X, V.11.X, V13.0 or V13.5 (Clinical Assessment License only).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VARIAN MEDICAL SYSTEMS BRASIL LTDA.; VARIAN MEDICAL SYSTEMS INC..

¿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
    1723
  • Fecha
    2015-11-12
  • 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 the product registration holder, the anomaly occurs only on sites that hold a Clinical Assessment License / Clinical Assessment License. For ARIA software that does not have this license available, they are not affected. An example of an intercurrence that may result from the problem in question: an e-Rx transmitted to the pharmacy, as well as the printed prescription, will not contain the intended administration instructions for the patient. Check more details in the Alert Message of the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/ac89d4804a9127ec8e81bf486c3ae08b/Message+of+Alerta+-+CP-21350+PNL-FSN-PTB- A.pdf? MOD = AJPERES #### UPDATED ON 8/24/2017, the company sent the completion report of the field action proving the software update, with registry change.
  • Causa
    When the user changes the "type" field of the prescription, after entering the administration instructions in the text box, the portion of the prescription instructions is not saved in the system database.
  • Acción
    Product field correction (software update, expected to be initiated with customers in March 2016). Recommendations to users, for any remedy request that includes Administration Instructions: 1) DO NOT select "Approve" if you have not yet saved the prescription by selecting "OK"; 2) Users MUST open the drug request except before approving the drug request to verify that the administration instructions are present. (a) If the Administration Instructions box is empty, the user MUST re-enter the text of the intended administration instruction AND SHOULD NOT modify the "Type" field after entering the text again in the Administration Instructions text box. This action will produce the anomaly. (b) The user MUST save the corrected remedy order by selecting "OK". (c) The user MUST open the corrected remedy application to verify that the Administration Instructions are present. If the text is present, the user can select "Approve" and continue with the workflow to print the prescription or send the e-Rx to an external pharmacy.

Device

ARIA Software (ARIA for Radiation Technology). Anvisa Registry No. 10405410013. Models at risk: V...

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.; VARIAN MEDICAL SYSTEMS INC.