Events

Alerte De Sécurité sur Oncentra Brachy Planning, Record no. 80569320017, Annex I: Products Affected

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 Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda..

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
    1605
  • Date
    2015-06-03
  • 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 company's statement, the magnitude of the error of calculation of the dose depends on the transformation of the registry and may range from 0 to 100% of the correct dose value. We have identified two clinical scenarios in which the problem may impact patient care: 1. Multi-modal imaging prior to the first fraction, in which the secondary data sets are used in contour definition and dose assessment. 2. Pre-treatment image examinations and plan adjustment based on contour definition and dose evaluation in the secondary data set (pretreatment). The isodose line function, which is commonly used for dose assessments in conjunction with the dose assessment functions mentioned above, is not affected by this problem. The company also reports that the problem was discovered during the introduction of a new treatment protocol at a client center on March 18, 2015. The client perceived the problem directly when comparing the DVH values ​​with the isodose lines during the evaluation plan. ##### Update of the field action: UPDATED ON 11/03/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    The manufacturer of the product has identified the possibility of incorrect dose calculations for regions of interest (rois) defined in a secondary series of images. it has been determined that the software may cause incorrect dose values ​​or display an incorrect dose when the following conditions are satisfied: 1. the identity recording method is not used, and 2. a treatment plan contains a primary series of images a and one or more secondary series of images b, and 3. the set of data b is recorded in data set a by means of an image registration procedure: surface compatibility, and 4. an roi is defined in data set b. the dose or dose values ​​displayed may be incorrect in some of the functions of the secondary series of pictures: • dose profile; • dvh chart (for rois in secondary images); • dvh table values ​​(in rois in secondary images); • dose statistics in case explorer (in rois in secondary images); • hipo (with rois in secondary images) note: there was no impact to patients or chance of impact to patients, even if the procedure had been continued.
  • Action
    The company that registers in Brazil is directed to repeat sampling of Regions of Interest defined in a secondary series of images in the primary series of images before the dose evaluation. Further information: Annex II - Letter to the Client

Device

Oncentra Brachy Planning, Record no. 80569320017, Annex I: Products Affected

Manufacturer

Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    ANVSANVISA