CareFusion is recalling nearly 350,000 infusion pumps due to a faulty sensor that may generate a false alarm and cause the pump to stop supplying the infusion to the patient.
The Class I recall pertains to the Alaris Pump Module, model No. 8100 (Large Volume Pump), manufactured between October 2011 and June 2015, as well as air-in-line (AIL) sensor kits (product numbers 147083-102 and 49000221) distributed within the same time frame. The recall affects 349,746 units in the United States.
The products have a faulty AIL sensor that may generate reoccurring false alarms, with each false alarm requiring the staff to clear the alarm to restart the infusion. If unaddressed by staff, the interruption of infusion could lead to "serious adverse health consequences or death," according to the recall. Those affected by the recall should call (888) 526-6018 or email email@example.com with any questions.
BD first alerted users to the issue in early December 2016 by way of a medical device safety notification. The notification also included instructions to follow if an AIL alarm occurred.
The FDA encourages healthcare professionals to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing this form or calling (800) 332-1088 for more information.