The U.S. Food and Drug Administration has issued a recall for the CareFusion 303, Inc., Alaris Pump Module (Model 8100), Version 9.1.18. CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because it may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. The firm received one report where the device malfunctioned when the “Delay Until” option was selected. The software failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm398178.htm |