Alaris Medical Systems
This article was originally published in The Gray Sheet
Executive Summary
U.K. Medical Devices Agency warns of possible over-infusion from Alaris' P1000, P2000, P3000 lines of syringe pumps due to obsolete software related to volume limit and bolus features, as well as a typographical error in product labeling. Clinicians are advised to contact Alaris for upgraded software, and to attach an interim label correcting the error. "The most serious effect of this error, if not detected by the user, is over-infusion due to the pump running at the Keep Vein Open rate instead of automatically stopping once the volume limit is reached," MDA states in Oct. 23 notice