Notificaciones De Seguridad De Campo acerca de HeartMate ll® System Controller, Model 105109

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 Abbott Laboratories.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    As follow-up to our most recent communication in september, 2015, we are advising you that thoratec corporation, an abbott laboratories company, is updating its alert guides, conducting a software upgrade and adding controller alignment markings for the heartmate ii® system controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations. a number of training and education improvements were completed in 2014 upon a voluntary field correction regarding the patient controller exchange process. as a result, we saw an 80% reduction in adverse event rates for system controller exchanges, and a 90% shift of system controllers being exchanged at home to being completed in the hospital, which is consistent with the instructions for use. despite this, patients continue to experience a very low level of adverse events (including serious injury or death), at a rate of o. 1%, as a result of unnecessary patient controller exchanges. system controller exchanges are best conducted by medical professionals in a controlled environment. .



  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
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