On February 2, 2023, the U.S. Food and Drug Administration (FDA) reported Smiths Medical’s recall of its CADD™ infusion system administration sets and cassette reservoirs because of tubing occlusions that may under- or not deliver medication and false no disposable attached (NDA) alarms that may prevent pump use. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.
Smiths Medical received reports of 1,571 incidents, 14 injuries, and two deaths related to the tubing occlusion issue and 9,101 incidents, 11 injuries, and no deaths related to the false NDA alarm issue. The recall affects more than 19 million sets distributed since June 15, 2018. FDA lists the recalled product codes in its medical device recall database.
Smiths Medical issued the recall because of two potential problems:
- Tubing occlusion can prevent delivery or cause under-delivery of medication: Manufacturing variations may cause the green CADD flow stop arm to compress and partially block the tubing before clinical use. If the occlusion does not resolve when an affected reservoir or administration set is connected to the pump, the pump may not detect the occlusion, resulting in under- or non-delivery of medication, though the pump will display that the infusion is running properly.
- False NDA alarm can prevent pump use: Manufacturing variations on certain CADD medication cassette reservoirs with flow stop may interfere with the pump detecting a properly attached CADD cassette. The pump will give an audible warning. If the audible warning is not resolved within two minutes, an NDA alarm will occur. The user must clear the alarm and resolve the cause of the NDA event before using the pump, resulting in the delay or interruption of therapy.
The recall issues can delay or interrupt therapy or underdeliver medication, which all have the potential to cause serious patient harm or death.
The following people may be affected by the recall:
- People who are treated using the CADD infusion system with CADD administration sets or medication cassette reservoirs
- Healthcare professionals and caregivers providing care using the CADD infusion system with CADD administration sets or medication cassette
- Distributors of CADD administration sets or medication cassette
On December 9, 2022, Smiths Medical notified consumers via an urgent medical device correction letter. For both recall issues, Smiths Medical recommended using an alternative CADD infusion sets for life-sustaining medications. Consumers can contact Smiths Medical customer service at 800-258-5361 for information on obtaining alternate CADD infusion sets.
For the tubing occlusion issue, Smiths Medical recommended that:
- Pharmacists immediately identify affected products and ensure the products are separated and labeled as affected by the recall to avoid use for life-sustaining medications.
- Pharmacists experiencing difficulty filling the cassettes of affected products should consider changing to a new infusion set and contact Smiths Medical’s global complaint management to report the event.
- Clinicians and patients must be aware that when using products affected by the recall with a CADD pump, although the medication may appear to be infusing normally, it may not be infusing at all or under-infusing and that the pump will not alarm.
- Clinicians can contact specialty pharmacies to discuss availability of alternative CADD infusion sets for life-sustaining medications. Depending on availability and patient situations, clinicians may consider switching patients to an alternative pump.
- Clinicians should prime the set using the pump and watch the fluid flow closely. If the fluid doesn’t flow properly or takes an abnormally long time to prime or if the pump displays a higher-than-expected priming volume, replace the reservoir or set. The priming volume is listed on the packaging for each administration set.
- If medication remains in the reservoir at the completion of the infusion, contact a clinician and Smiths Medical’s global complaint management to report the event.
- Clinicians should share the information on the recall with homecare patients and educate them about the recommended actions.
For the false NDA alarm issue, Smiths Medical recommended that:
- Pharmacists immediately identify affected products and ensure the products are separated and labeled as affected by the recall to avoid use for life-sustaining medications.
- Clinicians and patients should be aware that the pump may not adequately detect the cassette before or during an infusion because of the issue, which triggers the alarm.
- If a pump displays an NDA alarm, the user can attempt to resolve it by repositioning the CADD medication cassette reservoir when it’s connected to the pump, repositioning the reservoir by disconnecting from the pump and reattaching it to the pump, or replacing the reservoir.
- Alternatively, the user can remove the reservoir from the pump and push the plastic ridge toward the arch on the reservoir.
- If the user cannot resolve the NDA alarm, replace the cassette reservoir, although the issues may recur if the replacement reservoir is also affected by the recall.
- Clinicians should contact the pharmacy to discuss availability of alternative CADD infusion sets for patients receiving life-sustaining medications. Depending on availability and patient situations, clinicians may consider switching patients to an alternative pump.
- Clinicians should share the information on the recall with homecare patients and educate them about the recommended actions.
To report adverse events or product complaints, contact Smiths Medical’s global complaint management at 866-216-8806 or globalcomplaints@smiths-medical.com.
For additional information or technical assistance, contact Smiths Medical’s technical assistance at 800-258-5361.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experience using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.