Events

Notificaciones De Seguridad De Campo acerca de B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por B. Braun Melsungen AG.

¿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(21)
  • Fecha
    2014-04-29
  • 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=/b.braun-infusomat-perfusor-space-infusion-pumps-pole-clamps.-priority-2---warning&id=26cef925-9782-6eee-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
    Risk of delay or interruption to therapy.  issue 1: the irish medicines board (imb) has received an increased number of complaints in relation to breakage of the anti free-flow clip catch located inside the door of the b. braun infusomat space infusion pump.  issue 2: the imb has received a number of complaints of pump detachment involving the b. braun pole clamp when used to mount infusomat and perfusor space pumps.
  • Acción
    Issue 1: In relation to breakage of the anti free-flow clip catch located inside the door of the Infusomat Space infusion pump, the IMB advises that users:  (1) Follow the instructions outlined by the manufacturer in the device Instructions for Use (IFU) for loading and unloading of an infusion set when using the Infusomat Space. Specifically, if the door of the device is difficult to close, check the IV set and anti free-flow clamp (green) for proper installation.  (2) In accordance with the IFU, before opening the door, close the roller clamp and ensure that the door does not fall open completely. If the door opens to a horizontal position, check that the slide clamp (green) is properly occluding the IV set and the door extension hook is not broken.  (3) If the door hook is found damaged or broken, remove the pump from use.  (4) Ensure B. Braun is notified of the issue and arrange with the manufacturer for the device to be repaired appropriately.  Issue 2: In relation to detachment involving the B. Braun Pole Clamp when used to mount Infusomat and Perfusor Space pumps, the IMB advises users:-  (1) When mounting infusion pumps using the B. Braun pole clamp, ensure the pumps are secured in accordance with the manufacturer’s IFU.  (2) Do not use pole clamps which are damaged or missing clamp grids.  (3) Ensure B. Braun is notified of the issue and arrange with the manufacturer for the device to be repaired appropriately.

Device

B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps
  • Modelo / Serial
  • Descripción del producto
    B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps. Priority 2 - Warning
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG