Events

Field Safety Notices about B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by B. Braun Melsungen AG.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2014(21)
  • Date
    2014-04-29
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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
  • Notes / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / Serial
  • Product Description
    B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps. Priority 2 - Warning
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG