Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system.
The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.
According to a news release, lack of delivery or underdelivery may occur due to manufacturing variations. Those variations can potentially cause the green CADD Flow Stop arm to compress. This partially occludes the tubing before clinical use, Smiths Medical said.
If this happens, occlusion potentially fails to resolve when the CADD reservoir or administration set connects to the pump. The pump may not detect the occlusion as well. This could result in underdelivery or non-delivery of medication, even if the pump displays the proper running of the infusion.
Smiths Medical said its second issue relates specifically to CADD-Legacy pumps. The company announced the discontinuation of sales for these effective Dec. 31, 2022.
CADD-Legacy pumps may not detect the attachment of 50 mL and 100 mL CADD medication cassette reservoirs with flow stop to the pump. This could occur even when properly attached. When this happens, the pump initiates the NDA alarm if a double-beep warning isn’t resolved within two minutes.
The user must clear the alarm and resolve the cause of the NDA event before using the pump. The issue does not extend to 250 mL Flow-Stop and non-Flow-Stop CADD medication cassette reservoirs.
