CADD-Solis™ Ambulatory Infusion Pump

Issue

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