Events

Notificaciones De Seguridad De Campo acerca de Formula® Hemodialysis Machines

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Medtronic.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    To date, three thermal events that led to fire have been reported in three separate machines; one during a disinfection cycle, and two prior to patient use when the machines were switched on. while there was damage to each of these machines, no patients or healthcare providers were injured as a result of these events. the occurrence of such events is low, with a rate of approximately 0.01% of formula machines manufactured since 1998. based on our internal investigations, we determined the battery charge board to be the source of two of the events. the source of the third event could not be conclusively confirmed due to the extent of the damage to the board, but the available evidence is consistent with the other two events. we have determined that disconnecting the battery charge board will eliminate the possibility of the failure mode while a permanent solution is implemented. .

Device

Formula® Hemodialysis Machines
  • Modelo / Serial
    Formula®, Formula® 2000, Formula® PLUS, Formula® 2000 PLUS, Formula® Therapy, and Formula® Domus.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    AMPMDRS