Pump, Infusion, Pca
General Hospital · 21 CFR 880.5725
Recent MDR events
32,663 adverse event reports on file
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07767
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07770
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07771
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07772
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07773
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07774
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07776
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07778
- CADD Solis HPCA PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07782
- CADD-Solis Ambulatory Infusion PumpJul 31, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07785
Event type breakdown
Recalls
46 recall events for this product code
- Smiths Medical ASD, Inc.Open, ClassifiedMay 7, 2025
CADD Solis HSPCA Pump
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Z-1662-2025 · View FDA record ↗ - Smiths Medical ASD, Inc.Open, ClassifiedMay 7, 2025
CADD-Solis HPCA Ambulatory Infusion Pump;
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 injury or death.
Z-1667-2025 · View FDA record ↗ - Smiths Medical ASD, Inc.Open, ClassifiedMay 5, 2025
CADD-Solis Infusion Pump Models:
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Z-1681-2025 · View FDA record ↗ - Smiths Medical ASD, Inc.Open, ClassifiedNov 15, 2024
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
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 from the input plug.
Z-0466-2025 · View FDA record ↗ - Smiths Medical ASD Inc.Open, ClassifiedAug 3, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses:
CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.
Z-2419-2024 · View FDA record ↗ - Smiths Medical ASD Inc.Open, ClassifiedAug 3, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110.
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
Z-2420-2024 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedJun 18, 2015
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0.
Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD-Solis pumps. Binding of the Cassette/ Keypad Lock can occur after latching the CADD-Solis Medication Cassette Reservoir or Administration Set disposable to the pump. When binding occurs, it can prevent the key from fully rotating the Cassette/ Keypad Lock to the locked (e
Z-1813-2015 · View FDA record ↗ - Baxter Healthcare Corp.TerminatedApr 27, 2015
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication b
Potential for device malfunction resulting in flow when the device should not be flowing
Z-1536-2015 · View FDA record ↗ - Hospira Inc.TerminatedApr 23, 2015
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Z-1517-2015 · View FDA record ↗ - Hospira Inc.TerminatedApr 23, 2015
The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Z-1518-2015 · View FDA record ↗
Registered firms
60 firms currently registered for this product code
Carefusion 303, Inc
San Diego, CA, US
Integra Biotechnical, Sa De Cv
Tijuana Baja California, MX
Emsere Bv
Leiden Zuid-Holland, NL
Emsere, Inc.
Peachtree City, GA, US
Avanos Medical, Inc.
Alpharetta, GA, US
Sterigenics U.s., Llc
Corona, CA, US
Carefusion 303, Inc.
SAN DIEGO, CA, US
Icu Medical Costa Rica Ltd.
La Aurora de Heredia, CR
Med One Equipment Services, Llc
Sandy, UT, US
Quipment
Nancy Meurthe-et-Moselle, FR
Icu Medical, Inc.
Lake Forest, IL, US
Avent S. De R.l. De C.v.
TIJUANA Baja California, MX
Synergy Health Ast, Srl
Alajuela, CR
B. Braun Avitum Ag
MELSUNGEN Hesse, DE
Infusystem Inc.
Mississauga Ontario, CA
510(k) clearances
31 clearances for this product code
- Summit Medical Products, Inc.Aug 29, 2017
K162165 · ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
- Smiths Medical Ads, Inc.Aug 24, 2017
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)
- Hospira, Inc.Apr 8, 2016
K143612 · LifeCare PCA Infusion System
- Smiths Medical Asd, Inc.Dec 9, 2013
K130394 · CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
- B.Braun Medical, Inc.Nov 4, 2009
K092313 · PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
- Smiths Medical MD, Inc.Mar 7, 2008
K072144 · CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
- Baxter Healthcare CorpJul 15, 2005
K051253 · MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
- Alaris Medical Systems, Inc.Dec 10, 2004
K043299 · MEDLEY PCA MODULE, MODEL 8120