Overview

The Smiths Medical CADD®-Solis 2100 is an ambulatory infusion pump designed to deliver precise, reliable pain management therapy to adult and pediatric patients across a wide range of clinical environments — including post-operative care, oncology, trauma, critical care, labor and delivery, and home infusion. The pump is now manufactured and supported by ICU Medical following their acquisition of Smiths Medical’s infusion portfolio. Its compact form factor, weighing just 1.31 lbs with batteries installed, is purpose-built to support patient mobility without sacrificing clinical capability.

Delivery Modes and Therapy Flexibility

The CADD-Solis 2100 supports five delivery modes on a single platform: continuous infusion, patient-controlled analgesia (PCA), intermittent bolus, clinician bolus, and Programmed Intermittent Bolus (PIB) — including Programmed Intermittent Epidural Bolus (PIEB). This makes it the only ambulatory pump capable of combining PIB and PCA delivery, giving clinicians greater flexibility for epidural analgesia, nerve block, and post-surgical pain protocols. Rates are programmable in 0.1 ml increments, with a maximum combined delivery rate of 175 ml/h, and the pump accepts programming entries in ml, mg, or mcg to match institutional workflow.

PharmGuard® Safety Software and Drug Library

The CADD-Solis 2100 is fully integrated with the PharmGuard® Medication Safety Software ecosystem. The on-board library holds up to 500 therapy protocols, each built around a therapy type, qualifier, and drug designation. Pharmacists can use PharmGuard® Administrator software to create and manage custom protocol libraries with soft and hard dose limits, then push those libraries directly to pumps via USB or — when the optional CADD-Solis Wireless Communication Module is installed — wirelessly over the hospital network. PharmGuard® Server software also supports firmware updates, delivery history tracking, and fleet-wide compliance reporting, giving pharmacy and clinical teams full visibility into pump utilization.

Safety Features and Alarm System

Patient safety is central to the CADD-Solis platform. The pump includes a downstream occlusion sensor that alarms at 18 ±9 psi, an upstream occlusion sensor (active when using CADD administration sets), and an air detector capable of sensing bubbles as small as 150 mcL in high-sensitivity mode. Alarms are differentiated by color and sound — high-priority alarms display in red, medium-priority in amber, and low-priority in blue — allowing clinicians to quickly triage alarm urgency. The three-level security system (keypad, clinician, and administrator codes) limits access to programming functions and prevents unauthorized changes, while the cassette latch and lock mechanism provides an additional layer of medication security. The pump housing is sealed to an IPX4 splash-proof standard.

Power Options and Portability

The CADD-Solis 2100 supports three power configurations: four standard AA 1.5V alkaline batteries, the CADD-Solis rechargeable Li-ion battery pack, or an external AC adapter. The rechargeable pack charges fully in 4 hours or less within the pump’s operating temperature range. An internal lithium manganese dioxide battery provides up to 10 months of memory backup once charged for 250 hours at 68°F, ensuring delivery history and programming parameters are retained even when primary power is removed. Pump pouches and backpacks — available separately from Smiths Medical/ICU Medical — allow the system to accommodate cassette reservoirs from 50 ml to 250 ml, or flexible IV bags up to 3 liters, making it practical for both inpatient and ambulatory home use.

Administration Sets and Consumables

The CADD-Solis 2100 is designed for use exclusively with Smiths Medical CADD® brand administration sets and cassette reservoirs. Compatible options include CADD™ medication cassette reservoirs with CADD® extension sets, and CADD® administration sets (with or without the Flow Stop free-flow protection feature). The Flow Stop feature automatically halts flow when the cassette is separated from the pump, providing an important safeguard against unintended gravity infusion. For epidural and subarachnoid routes, Smiths Medical and ICU Medical strongly recommend using NRFit-connector sets to reduce misconnection risk. IPR Medical stocks CADD-compatible administration sets and cassette reservoirs, giving facilities a convenient single-vendor source for both pumps and consumables.

FDA Device Corrections and Safety Bulletins

The CADD-Solis ambulatory infusion pump platform has been the subject of multiple FDA Class I device corrections and safety bulletins. Facilities operating these pumps should review each of the following and confirm corrective actions have been completed.

2024 Software Correction (Class I) — Pre-v4.2 Pump Software: On February 27, 2024, Smiths Medical issued an Urgent Medical Device Correction letter for CADD-Solis pumps running software versions earlier than v4.2 (and CADD-Solis VIP pumps running earlier than v1.6), and PharmGuard Server software earlier than v2.6. Outdated software versions may cause failure to alarm for upstream occlusions, incorrect delivery behavior, or other potentially serious malfunctions. The FDA classified this as the most serious type of correction. Facilities were directed to locate all affected pumps, ensure all users are informed, install the latest software, and return a completed response form. Pumps with current software (v4.2 or later) are not affected. IPR Medical can assist with software update verification and service.

2024 Battery Pack Correction (Class I) — Li-ion Rechargeable Battery Packs: On July 16, 2024, Smiths Medical issued a correction letter for CADD-Solis rechargeable battery packs due to a risk that physical damage to the battery outer casing could cause an internal short circuit, melt the pack housing, and prevent recharging. Facilities were instructed to inspect all battery packs for signs of damage and immediately replace any damaged packs with an undamaged CADD-Solis rechargeable battery pack or four AA alkaline batteries. Pumps themselves are not required to be returned — only affected battery packs need replacement.

False Upstream Occlusion (USO) Alarm Correction: Smiths Medical issued a notification regarding a condition where a false upstream occlusion alarm could be triggered when a CADD administration set (not a cassette reservoir) was used and an infusion was delayed for more than one hour after the initial prime. This high-priority alarm stops active infusions and cannot be cleared until resolved. The issue does not occur when using cassette reservoirs, when the USO alarm is disabled, or when a KVO rate is programmed. A software update addresses this condition.

Wireless Communication Intermittent Connection Alarm: Smiths Medical notified affected customers that CADD-Solis pumps equipped with the optional wireless communication module may trigger a “Wireless Module Intermittent Connection” high-priority alarm — stopping an active infusion — if hospital wireless network setting changes are not compatible with the module. Facilities were advised to validate any wireless network changes against the module before deployment and, if the alarm recurs, to revert to compatible network settings or disable the wireless function.

Important: The software correction for pre-v4.2 pumps does not require returning the pump — the corrective action is a software update. For battery pack concerns, damaged packs should be replaced with a new CADD-Solis rechargeable pack or four AA batteries; damaged packs should be reported to the manufacturer. Because FDA device corrections and safety communications may be updated or expanded after the date of this listing, IPR Medical recommends that facilities also check the FDA’s official resources directly to ensure they have the most current information.

FDA resources for the most current correction and recall information:
– FDA Medical Device Recalls Database
– FDA Medical Device Safety

IPR Medical — Your CADD-Solis 2100 Service Partner

IPR Medical buys, sells, repairs, and stocks parts and administration sets for the CADD®-Solis 2100. Whether you need a replacement unit, depot-level repair, software update verification, or a reliable source for CADD-compatible consumables, our team is ready to help. We maintain an active inventory of CADD-Solis pumps and parts to keep your fleet running without delays.

IPR Medical buys, sells, repairs, and stocks parts and IV sets for the CADD®-Solis 2100. Contact us at 855-477-8866 or cs@iprmed.com.