Medfusion Syringe Infusion Pumps

The calibration of the force sensor used to detect occlusions may shift over time. If the force sensor calibration shift is large enough, the pump will display a system failure alarm (including force sensor BGND test, force sensor bridge test, or force sensor test). If the calibration shift is not large enough to trigger a system failure alarm, there may be a slight increase in the threshold to detect an occlusion. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly.

Recall start date: August 8, 2023