CADD-Solis™ Ambulatory Infusion Pump

Under certain conditions, a CADD-Solis™ pump may trigger an erroneous (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.

A USO alarm may potentially occur if all these conditions are met:

• using a CADD administration set (i.e. not a medication cassette reservoir), and
• enabling the upstream occlusion alarm, and
• not programming keep vein open (KVO) or continuous rate, and
• priming or infusing shortly after attaching the administration set and the next infusion does not occur for approximately one hour or longer.

This issue will not occur when using a medication cassette reservoir, if the USO alarm is disabled, if the KVO setting is programmed, or if a continuous rate setting is programmed.

Recall start date: April 8, 2025