Events

Notificaciones De Seguridad De Campo acerca de Baxter Coiled Tube Infusors

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland 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
  • Número del evento
    SN2014(19)
  • Fecha
    2014-04-24
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/baxter-coiled-tube-infusors.-priority-2-warning&id=38d0f925-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Following a review of customer complaints for over-infusion, baxter has identified an error in the directions for use for the coiled tube infusor system. as outlined in the attached fsn, direction for use #5 is incorrect for the coiled tube infusor. the nominal (labelled) flow rate is achieved when the elastomeric reservoir is positioned 6-8 inches (15-20cm) below the distal luer lock and not when positioned at the same height as stated in the directions for use.  baxter has indicated that the following products which have been supplied to the irish market are impacted by this issue.  product codes product name 2c1071kjp single day infusor 2 ml/h system 2c1073kjp half day infusor sv 5 ml/h system 2c1080kjp multiday infusor 0.5 ml/h system.
  • Acción
    The IMB advise that users:  (1) Follow the instructions outlined by the manufacturer in the field safety notice (FSN) attached.  (2) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice and the attached FSN on to any end users or organisations where these devices may have been distributed.

Device

Baxter Coiled Tube Infusors
  • Modelo / Serial
  • Descripción del producto
    Baxter Coiled Tube Infusors. Priority 2 – Warning
  • Manufacturer
    Baxter

Manufacturer

Baxter