Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
The US Food and Drug Administration (FDA) has classified three recent safety notices from Smiths Medical regarding its CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP pumps as Class I recalls—the agency’s most serious designation.
The corrections involve updates to device instructions rather than product removals, but the FDA warns that failure to follow the new guidance could lead to serious injury or death depending on the clinical context and medication being infused. Smiths Medical has not reported any injuries or fatalities associated with the issues.
The updates address the following concerns:
- Infusion Pump False Occlusion Alarm: Under certain conditions, a CADD-Solis pump may trigger a false Upstream Occlusion (USO) Alarm. The erroneous USO alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD Administration Set and the next prime or infusion of the same CADD Administration Set. The USO Alarm is a high-priority alarm that will interrupt an ongoing infusion or delay initiation of an infusion. The pump cannot resume or start an infusion until the alarm is cleared.
- Infusion Pump Thermal Damage Issue: Damage to the rechargeable battery pack circuit board, Wireless Communication Circuit Board, or battery separators is associated with the potential for thermal damage in affected infusion pumps. Damage to or inoperable batteries may lead to a delay in therapy or interruption of therapy. The user would be alerted with the normal “Low Battery” or “Depleted Battery” alarms. The presence of excessive heat from damaged or shorted components is also possible, which may result in a thermal injury.
- Infusion Pump Intermittent Connection Issue: CADD-Solis pumps may lose communication with the CADD wireless communication module if wireless network setting changes on the hospital network are not compatible with the CADD wireless communication module. This may result in a “Wireless Module Intermittent Connection” high priority alarm, which will stop an ongoing infusion. When this alarm triggers, the pump must be power cycled to clear the alarm.
Smiths Medical has issued updated use instructions to affected customers and continues to monitor the situation. The FDA urges healthcare professionals to follow the revised guidance to ensure patient safety.
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