CADD Pump Infusion Set Recall Issued Over Risk of Medication Delivery Failure Risk

Smith Medical has issued a recall for infusion sets used with CADD pumps, due to a risk that they may malfunction and under-deliver fluids or medication needed for life-sustaining therapy.

The CADD Pump Infusion Sets recall was announced by the U.S. Food and Drug Administration (FDA) on January 5, warning healthcare providers that the infusion systems may signal false alarms or supply insufficient fluid to patients if the tubing becomes blocked.

The infusion systems are designed to programmatically deliver specified amounts of chemotherapy, fluids and antibiotics to patients based on the healthcare provider’s judgement. The sets are equipped with medication cartridges and tubing that connects to the infusion pump.

According to the recall announcement, a manufacturing defect may allow the green CADD Flow Stop arm to partially obstruct the tubing when delivering fluids to patients. Healthcare professionals are being warned the pump will not display an error in the dosage delivery.

Officials indicate patients could receive a lack, or under delivery, of life sustaining fluids, increasing the risk of serious injury or death.

While no reports of injuries or deaths were outlined in the recall announcement, healthcare professionals are being instructed to follow a specific series of instructions to avoid possible harm to patients.

Smith Medical also indicates there is a second problem with the CADDTM Infusion System Infusion Sets, which involves false alarms. The CADD-Legacy pumps may not detect when 50 ml and 700 ml CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump, even when they are properly attached.

If the attachments are not recognized, the pump will signal a NOA alarm. The manufacturer states that to address the issue, the user must clear the alarm and resolve the cause of the NOA event before using the pump. The false alarm problems are isolated to CADD-Legacy pumps, which Smiths Medical stopped selling in December 2022.

Smith Medical issued an Urgent Medical Device Correction Letter to customers on December 12, 2022, outlining the potential risks related to both issues. The letter provided the specific list of affected products with device-specific instructions.

For additional questions or concerns regarding the recall, customers may contact Smith Medical’s Global Complaint Management at 1-(866)-216-8806 to report adverse events or product complaints, or for Technical Assistance call 1-(800)-258-5361.