Events

Alerte De Sécurité sur 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).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par VARIAN MEDICAL SYSTEMS BRASIL LTDA.; VARIAN MEDICAL SYSTEMS INC..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1723
  • Date
    2015-11-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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.