B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps 에 대한 현장 안전성 서한

Field Safety Notice

SN2014(21)

2014-04-29

Ireland

HPRA

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

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.

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.