The cover is intended to stop tampering with the infusion presumably by those unauthorised to do so. Operning of the cover without a key or breaking the cover is obviously not the method described in the operating manual thus the manufacturer cannot be held responsible. The issue, in my opinion, is whether the cover is "fit for purpose" I suppose. You probably do have a point and if the pump is configured for PCA only then you are correct the pump does not alarm (when it is in standby - between bolus doses); my apologies. The operation of alarms, etc, depends on how the pump is configured and whether it's infusing when the cover is opened and the syringe is tampered with. The infusion can also be suspended without opening the cover (i.e. tampering is possible without breaking the cover). Should the capability of stopping an infusion without a key be reportable to the MHRA do you think?
