Smiths Medical Issues Correction Letter for CADD Infusion Sets

Smiths Medical issued an Urgent Medical Device Correction Letter concerning two potential issues with its CADD infusion system sets related to possible lack of delivery or underdelivery and false no disposable attached (NDA) alarms.
 
The lack of delivery or underdelivery issue can occur due to manufacturing variations that may cause the green CADD flow stop arm to compress and partially occlude the tubing before use. If this occurs, the occlusion may not resolve when the CADD reservoir or administration set is connected to the pump and the pump may not detect the occlusion. Underdelivery or non-delivery of medication can occur as a result, despite the pump displaying the infusion is running properly.
 
The false NDA alarms are specific to CADD-Legacy pumps, which Smiths Medical will stop selling effective December 31 of this year. The pumps may not detect that 50 and 100 mL CADD medication cassette reservoirs with flow stop are attached to the pump when they are properly attached. The pump will then begin an NDA alarm if the double-beep warning isn’t resolved within two minutes. Users must clear the alarm and resolve the NDA event cause before using the pump.
 
A copy of the customer notification, which outlines potential risks associated with both underdelivery and NDA alarms, lists the affected products, and provides specific actions users should take in the event of such occurrences, can be found here.