Fears that confusion over manufacturer’s instructions could mean clinical staff failing to hear vital alarms on infusion pumps has led to a Medical Device Alert being issued to UK hospitals and medical centres.
The warning concerns Plum A+ single channel infusion pump systems manufactured by Hospira.
The alert, issued by the Medicines and Healthcare products Regulatory Agency (MHRA) affects the Plum A+ hyperbaric infusion system with product code 11005; the Plum A+ single channel infusion system with codes 11971 and 12391; and the Plum A+ infusion pump with the code 20792.
The concern comes after it was discovered that the operation of the alarm volume control is not consistent with the operator’s manual. On some pumps, the knob is turned clockwise to increase the volume, on others it is turned anticlockwise. It is feared this could lead to clinical staff failing to hear the alarm should it be accidentally silenced.
To address the problem, Hospira will be updating the user manual and providing labels for each device to identify the correct operating direction.
In the meantime the company is urging staff to make sure they are aware of the correct way to turn the volume dial, to ensure they check the alarm warning levels, and to arrange for volume direction labels to be fixed to all devices.
For the full warning, click here.