Notificaciones De Seguridad De Campo acerca de AlarisTM Syringe Pump – (CC, GH, GS, PK and TIVA)

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 CareFusion International.

¿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
  • 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
    Carefusion has identified that the alaris syringe pump & the nipro syringe are no longer compatible and nipro be removed from the list of recognised syringes. .

Device

  • Modelo / Serial
    AlarisTM CC, Universal 80033UNN0 AlarisTM CC, Universal, RS232 80033UNN1 AlarisTM CC, Universal, Dedicated 80033UND0 AlarisTM CC, Universal, Dedicated, RS232 80033UND1 AlarisTM CC Syringe Pump with Plus Software 8003MED01 AlarisTM CC with GuardrailsTM Safety Software, Universal, Dedicated 80033UND0-G AlarisTM CC with GuardrailsTM Safety Software, Universal, Dedicated, RS232 80033UND1-G AlarisTM CC Guardrails Syringe Pump with Plus Software 8003MED01-G AlarisTM CC Syringe Pump with Plus Software 8003TIG01 AlarisTM CC Guardrails Syringe Pump with Plus Software 8003TIG01-G AlarisTM GH, Universal 80023UN00 AlarisTM GH, Universal, RS232 80023UN01 AlarisTM GH Syringe Pump with Plus Software 8002MED01 AlarisTM GH with GuardrailsTM Safety Software, Universal 80023UN00-G AlarisTM GH with GuardrailsTM Safety Software, Universal, RS232 80023UN01-G AlarisTM GH Guardrails Syringe Pump with Plus Software 8002MED01-G AlarisTM GH Syringe Pump with Plus Software 8002TIG01 AlarisTM GH Guardrails Syringe Pump with Plus Software 8002TIG01-G AlarisTM GS, Universal 80013UN00 AlarisTM GS, Universal, RS232 80013UN01 AlarisTM PK Syringe Pump, Universal 80053UN01 AlarisTM TIVA, Universal, RS232 80043UN01
  • Manufacturer

Manufacturer