Events

Notificaciones De Seguridad De Campo acerca de ARTIS/EVOSYS DIALYSIS SYSTEM

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.

¿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
    2016-07-20
  • 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 distributed an f sn (ref. annex 1 fsn fa—2014—010) in december 2014 to advise the user of the possibility that foam may have formed in the venous blood line when the extracorporeal circuit was primed using on—line priming. the f sn provided additional information on how to perform priming in case the specific dialyzer in use generates foam in the venous chamber. the number of reports of foam in the venous chamber significantly decreased with the application offsn fa-2014—010 recommendation as a collateral effect of the same problem, i.E. residual air and foam after priming, it has been observed an increased probability of air alarms occurrence. it has to be clarified that air alarm is not a risk in itself and is intended to prevent infusion of air which might be dangerous to the patient. this alarm stops the blood pump and interrupts the treatment until resolution by the user. in some cases it was reported that a few minutes after resolving an occurrence of air alarm and restarting the blood pump the patient experienced symptoms commonly repofied as hypotension. this typically followed a prolonged blood pump stop associated to a problematic air alarm troubleshooting.

Device

ARTIS/EVOSYS DIALYSIS SYSTEM
  • Modelo / Serial
  • Manufacturer
    Baxter

Manufacturer

Baxter