Infusion Pump Recalls Affect More Than 300,000 CADD-Solis Portable Devices: FDA

Smiths Medical has issued three recalls addressing issues with infusion pumps, which may interrupt or delay critical therapy.

Federal health officials have announced multiple recalls for Smiths Medical CADD-Solis Infusion Pumps due to malfunctions that could potentially result in serious injury or death.

The CADD-Solis Ambulatory Infusion Pump is a mobile, battery-powered device that is used in hospitals to administer medication for pain management, including post-operative care, trauma, critical care, labor and delivery, oncology, and regional anesthesia. For outpatient care, the CADD-Solis VIP pump is used by patients or caregivers.

According to the recall notices, if one of the devices experiences issues or stops working while in use, patient fluids or medications may be improperly delivered, potentially resulting in over- or under-medication, which can cause serious adverse health consequences.

False Alarm Issue

The U.S. Food and Drug Administration (FDA) announced a Smiths Medical Infusion Pump False Alarm Recall on June 3, for all CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps, warning that under certain conditions, the pumps may trigger a false Upstream Occlusion (USO) alarm, interrupting ongoing infusions or delaying new ones.

Upstream occlusion occurs when a blockage no longer allows fluid to properly flow through the device. Once the alarm is triggered, the pump cannot resume infusion until it is cleared, potentially resulting in serious harm for the patient.

To clear the alarm, users should remove and reattach the administration set and confirm there is no actual upstream occlusion.

The false USO alarm may occur when:

• A CADD administration set is used
• The USO alarm is enabled
• No Keep Vein Open (KVO) or Continuous rate is programmed
• Priming or infusing occurs shortly after set attachment, but the next infusion is delayed for one hour or more

Updated instructions for the CADD-Solis Ambulatory Infusion Pump and CADD-Solis VIP Ambulatory Infusion Pump were issued by Smiths Medical in an Urgent Medical Device Notification on April 10. 

Thermal Damage Risk

The FDA also announced a Smiths Medical Infusion Pump Thermal Damage Recall on June 3, warning that certain pumps or their components may overheat and melt if the internal circuit board of the rechargeable battery pack or Wireless Communication Module is damaged. In addition, battery separator damage or foreign material in the battery compartment may cause electrical shorts. These issues could result in patient burn injuries or interrupted therapy.

Users are cautioned that damaged batteries may trigger “Low Battery” or “Depleted Battery” alarms.

This recall affects certain CADD-Solis Ambulatory Pumps and CADD-Solis VIP Ambulatory Infusion Pumps. Affected customers were notified on April 10 and instructed to:

• Visually inspect battery packs and modules for damage
• Avoid using damaged components
• Check the battery compartment for fluid or debris before inserting batteries
• Contact Smiths Medical Technical Support for repairs

Intermittent Wireless Connection Issue

A Smiths Medical Infusion Pump Intermittent Connection Issue Recall was also announced on June 3, for CADD-Solis Pumps with software versions 4.0 through 4.3, which may lose connection to the wireless communication module if network settings are incompatible. This could trigger a “Wireless Module Intermittent Connection” alarm and stop infusion, which may lead to serious patient injury or death.

Users were advised to validate network changes for compatibility with the pump’s wireless module before implementing them on April 10. If the alarm recurs or cannot be cleared by restarting the pump, users should revert to prior settings or disable the wireless function.

Although Smiths Medical has not received reports of serious injuries or deaths as a result of any of these issues, the FDA has classified all three recalls as Class I, which is the most serious type.

Distributors of the affected products are advised to forward customer lists to Sedgwick at icumedical3393@sedgwick.com for notification purposes.

Customers in the U.S. with questions, or those experiencing adverse events or quality issues, should contact Smiths Medical at globalcomplaints@icumed.com or call 1-866-216-8806.