Events

Safety Alert for Brachytherapy Systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Nucletron Operation B.V..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    A1708-389
  • Event Number
    2013EBC-0010303
  • Date
    2017-08-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    Oncentra Brachy Planning System Version 4.5
  • Product Description
    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.
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NIDFSINVIMA