An Evaluation of Induced Failure Modes in the Belmont® Rapid Infuser.

Overview

BACKGROUND: Rapid infusers are vital tools during massive hemorrhage and resuscitation. Sporadic reports of overheating and shutdown of the Belmont® Rapid Infuser, a commonly used system, have been attributed to 1-sided clot blockage of the fluid path. We investigated multiple causes of failure of this device. METHODS: Packed red blood cells and thawed fresh frozen plasma with normal saline solution were used as base fluids for serial 10-minute trials using standard disposable sets in 2 Belmont devices. Possible contributors to device failure, including calcium-containing solutions and external leakage currents, were evaluated. Thermographic images of the heater and disposable cartridges were recorded. The effects of complete unilateral clotting were modeled by sealing half of the disposable cartridge with epoxy. RESULTS: Clotting on the surface of the heat exchanger coil increased with calcium concentration and was only observed at calcium concentrations >12.0 mmol/L (P < 0.0001) in a 1:1 plasma:red blood cell mixture, resulting in high-pressure downstream occlusion alarms and interruption of flow. CONCLUSIONS: Clot-based occlusion can be induced in the Belmont Rapid Infuser under unrealistic conditions. In the absence of complete unilateral flow blockage, we did not observe any significant overheating of the infuser under extreme operating conditions.