[abstract] EVALUATING ALARIS IV INFUSION SYSTEM FOR FUNCTIONAL ACCURACY AND SAFETY UP TO 6 ATA

Abstract

BACKGROUND: The Alaris System infusion pump (AIP, Alaris Medical Systems, San Diego, CA) has been tested and approved for use in multiplace hyperbaric chambers[1]. However, the accuracy of the delivery rate under these conditions has not been published. The goal of this study was to evaluate the AIP functional accuracy and safety under different hyperbaric conditions for different infusion rates. MATERIALS AND METHODS: Two Alaris System, Point-of-Care Unit, 8000 Series, five Pump Modules, 8100 Series, three Syringe Modules, 8110 Series were subjected to various atmospheric pressures (1, 2, 2.45, 3.06, 6 ATA), infusion durations and infusion rates (1, 5, 10, 15, 20 mL/h for syringe modules and 1, 50, 75, 125, 250 mL/h for IV tubing pumps). The Point-of-Care Unit, Pump Modules, and Syringe Modules were wrapped with commercially available clear plastic bags and purged with nitrogen gas to minimize the risk of fire. Actual flow rates were measured by timed collection of 0.9percent normal saline; volumes were measured gravimetrically. AIPs were programmed to start infusing at each set rate 5 minutes after the chamber reached a test depth and to stop infusing when a set infusion volume had been completed (times typically 29.5 to 30 minutes). Measured rate was compared with preset rate. Variability was assessed by calculating coefficient of variation (CV). The results were compared with the manufacturer's specificationRESULTS: Twenty-five sets of observations, forty data samples, were obtained (see table 1). CV of infusion rate was inversely related to infusion rate; CV increased with ambient pressure. Syringe modules had a higher CV than pump modules. The variability measured was within the manufacturer's specifications for the device. There were no malfunctions that were attributable to changes in atmospheric pressurINSERT TABLE FROM PICTURECONCLUSION: We conclude that the AIP system is able to function accurately and safely up to 6 ATA under the conditions tested1. Medley Medication Safety System Specifications, Alaris Medical Systems.