Events

Notificaciones De Seguridad De Campo acerca de Heater-Cooler

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 LivaNova.

¿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
    2016-11-11
  • 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
    Over the past two years, livanova1 and the broader cardiac surgery community has learned a great deal about a newly-identified infection risk to open-heart surgery patients called nontuberculous mycobacterium (“ntm”). ntm are widespread in nature and are commonly found in the soil, natural water, drinking water distribution systems, and household and building plumbing, especially in recirculating hot water systems in hospitals and apartment buildings. ntm are typically not harmful, but in rare cases may cause infections in very ill patients or individuals with compromised immune systems. as the market leader for heater-cooler devices, livanova is committed to patient safety and supporting the clinical community who use our devices. we take seriously the rare but concerning potential risk of ntm infections. we are committed to ensuring clinician confidence in our heater-cooler devices, which are a critical part of cardiac surgery procedures. in this regard, we would like to provide you with a further update on this important industry issue. .

Device

Heater-Cooler

Manufacturer

LivaNova