About the Recall:
Smiths Medical has issued a voluntary Medical Device Correction for potential issues with CADD Infusion system sets.
Smiths Healthcare is implementing this correction due to two issues.
- Lack of delivery or under-delivery related to tubing occlusion;
- False “No Disposable Attached (NDA)” alarms
The risk for issue 1 is if the tubing is occluded under the Flow Stop arm, the pump cannot detect the occlusion and may not infuse as intended. To date, Smiths Medical has received reports of 14 serious injuries and two deaths potentially related to this issue.
The risk for issue 2 is the potential that CADD-Legacy pumps may not detect that 50mL and 100 mL CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump when the cassettes are properly attached. This will initiate an NDA alarm if the NDA double-beep warning is not resolved. To date, there have been 11 reports of serious injuries and zero reports of deaths potentially related to this issue.
If you have any questions about the information provided in this communication, you may contact Smiths Medical using the following information: