# K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Feb 1, 2013 after 637 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960826 (1996). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
6 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072144: Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator, Smiths Medical MD, Inc. (2008) Summary page 1.
- K960826: Cadd-Prizm Model 6100 Pump, Sims Deltec, Inc. (1996) Summary page 1.
- K082783: Cadd -Solis Medication Safety Software:  Administrator and Point-of-Care, Smiths Medical MD, Inc. (2008) Summary page 1.

## Most influential descendants
- K130394: Cadd -Solis Ambulatory Infusion Pump, Version 3.0 (2013), 4 descendants of its own
- K170982: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (2017), 3 descendants of its own
- K232793: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets (2024), 1 descendant of its own
- K140783: Halo Ambulatory Infusion System (2014), 1 descendant of its own
- K242660: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (2024), 0 descendants of its own

## Recalls of this device
- Apr 10, 2025 · Class I · Z-1682-2025: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- Apr 10, 2025 · Class I · Z-1668-2025: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient
- Jul 16, 2024 · Class I · Z-0222-2025: Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to meltin
- Jun 26, 2024 · Class II · Z-0466-2025: The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate fr
- Feb 27, 2024 · Class I · Z-2421-2024: The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarach
- Mar 24, 2020 · Class I · Z-0107-2022: Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recogn

## Indications for use
The CADD-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion. PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patient-controlled analgesia. Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate. Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval. Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume. Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion. The CADD-Solis Medication Safety Software - Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump or CADD-Prizm PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software - Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software - Administrator to the CADD-Solis Ambulatory Infusion Pump and CADD-Prizm PCS II Ambulatory Infusion Pump (software revision H or higher).

Source page: https://510kreport.com/device/K111275
Methodology: https://510kreport.com/methodology