Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System Infusion Sets for Use with CADD Pumps

MINNEAPOLIS, Dec. 12, 2022 /PRNewswire/ — Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or underdelivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.

The first issue, lack of delivery or underdelivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use. If this happens, there is a potential that the occlusion does not resolve when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in underdelivery or non-delivery of medication, despite the pump displaying that the infusion is running properly.