Events

Alerte De Sécurité sur Brachytherapy Systems

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Nucletron Operation B.V..

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
    A1708-389
  • Numéro de l'événement
    2013EBC-0010303
  • Date
    2017-08-31
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer states that the routes of the measured sources of the referenced applicators, with a step size of the source of 2.5mm for the microselectron deferred charging device, constitutes the source of the alert, if this model of applicator is used to create an unplan, although the size of the step of the default source of the deferred loading device is 5.0mm, the size of the ovoid passage in the form of a ring or semicircular will be incorrect, 2.5 m will be indicated, although the deferred loading device will administer a dose at 5.0 mm. the error is detected during the approval of the plan, which may lead to the occurrence of potentially serious adverse events on the patient.

Device

Brachytherapy Systems
  • Modèle / numéro de série
    Oncentra Brachy Planning System Version 4.5
  • Description du dispositif
    Indicated for an operator to apply, by remote control, a radioactive source in the body through an interstitial, intracavitary, intraluminal, bronchial, endovascular, intraoperative applicator, radiation therapy for the treatment of cancer. Transplant applicators and tubes, an integral part of the brachytherapy system, are used to apply the radiation directly to the patient at the specific sites selected by the physician and are the only part of the system that has contact with the patient.
  • Manufacturer
    Nucletron Operation B.V.

Manufacturer

Nucletron Operation B.V.
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    NIDFSINVIMA