Events

Notificaciones De Seguridad De Campo acerca de Artiset bloodline

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 Baxter International, Inc. .

¿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
    Baxter is issuing a safety alert communication to inform customers of the potential for disconnection of the artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. baxter has identified a potential for increased likelihood of disconnection during post-market surveillance activities. the arterial and venous patient connectors are designed in compliance with the applicable international standards iso594 and iso8638, allowing safe connection to vascular accesses. the post-market surveillance reports of disconnection of the artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. to address this issue, baxter is providing additional instructions on how to properly connect the devices. .

Device

Artiset bloodline

Manufacturer

Baxter International, Inc.