Smiths Medical Issues Urgent Medical Device Correction Letter About Potential Issues With CADD™ Infusion Sets
On January 5, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-letter-notifying-customers-potential-issues?utm_medium=email&utm_source=govdelivery#recall-announcement) that Smiths Medical issued a December 12, 2022, urgent medical device correction letter to notify customers of two potential issues with CADD infusion system infusion sets because of potential under or no delivery and false no-disposable-attached (NDA) alarms.
Under or no delivery could result from manufacturing variations that might cause the green CADD flow stop arm to partially compress and occlude the tubing before clinical use. That may prevent the occlusion from resolving when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion, despite it displaying that the infusion is running properly.
NDA alarms are specific to CADD legacy pumps, and the pumps may not detect that the 50 ml and 700 ml CADD medication cassette reservoirs with flow stop are properly attached to the pump. If it happens, the pump will initiate an NDA alarm if the NDA double-beep warning is not resolved within two minutes. The user must clear the alarm and resolve the NDA event before resuming the pump. The issue does not affect the 250 ml flow stop and the non-flow stop CADD medication cassette reservoirs.
The customer notification letter listing the potential risks associated with both under delivery and NDA alarms, the affected products, and specific actions users should take in the event of such occurrences, are available on Smiths Medical’s website (https://www.smiths-medical.com/-/media/M/Smiths-medical_com/Files/fa2211-01-cadd-us-customer_communication.pdf).
To report adverse events or product complaints, contact Smiths Medical’s global feedback at firstname.lastname@example.org (mailto:email@example.com) or 866-216-8806. For technical help or additional information, contact Smiths Medical’s technical assistance at 800-258-5361.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.