CADD Medical Device Correction

ICU Medical recently released the following statement regarding two issues with CADD™ Infusion System Infusion Sets for use with CADD pumps.



“Manufacturing variations may cause the green CADD Flow Stop arm to compress and partially
occlude the tubing before clinical use. If this occurs, there is a potential that the occlusion does
not resolve when an affected 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.

CADD Flow Stop Medication Cassette Reservoirs and CADD Flow Stop Administration Sets
provide free-flow protection. By design, a green, spring-loaded pivoting arm automatically
squeezes the tubing closed when the reservoir or administration set is not installed on a pump.
Connecting the reservoir or administration set to the pump causes the pump to push the Flow
Stop arm, enabling fluid flow through the tubing. In certain circumstances, the tubing may
remain occluded even though the CADD reservoir or administration set is loaded into the pump.”



“There is a potential that CADD-Legacy pumps may not detect that 50 mL and 100 mL CADD
Medication Cassette Reservoirs with Flow Stop are attached to the pump when the
cassettes are properly attached. This issue does not impact 250 mL Flow-Stop and non-Flow
Stop CADD Medication Cassette Reservoirs.

Manufacturing variations on certain CADD Medication Cassette Reservoirs with Flow Stop may
interfere with the pump detecting a properly attached CADD cassette. In such situations, the
CADD-Legacy pump will issue a “No Disposable Attached (NDA)” double-beep audible warning
if the pump cannot determine that the CADD cassette is properly attached. The pump will initiate
an NDA alarm if the NDA double-beep warning is not resolved within 2 minutes. The user must
clear the alarm and resolve the cause of the NDA event before using the pump.

As a reminder, Smiths Medical announced the discontinuation of the sale of CADD-Legacy pumps,
effective December 31, 2022.”

Scroll to page 6-8 for affected SKU’s.

Alternative products are listed on page 11.