SMITHS MEDICAL

CADD-SOLIS · Anesthesiology

510(k): 5 Recall: 10 UDI: 0 MAUDE: 10 Class.: 59

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510(k) Clearances (5)

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

2013-12-09

Substantially Equivalent

CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE

2013-02-01

Substantially Equivalent

CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE

2008-12-17

Substantially Equivalent

LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP

2008-04-25

Substantially Equivalent

CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

2008-03-07

Substantially Equivalent

Recalls (10)

CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL,

2025-04-10

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.

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION

2025-04-10

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.

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0

2024-07-16

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 melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.

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

2024-06-26

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.

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 2

2020-03-24

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 recognized by the pump and may not alarm to notify the clinician.

CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,

2016-10-31

20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. Th…

CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: 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-S

2014-09-29

Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.

Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical w

2011-05-10

Reports of non-delivery/ significant under-delivery of fluids when the CADD Medication Cassette Reservoir is not correctly latched to the pump. EXPANDED: On 7/14/11, Smith Medical expanded this recall to include all consignees with affected pumps.

Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, and 21-2102-51.

2011-01-13

Reports of the Cassette Lock mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump.

Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403.

2010-01-27

Potential for the power cord's prongs to crack and fail at/or inside the plug. Other medical device manufacturers have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths Medical has received no reports of incidents regarding the use of the affected Electri-Cord power cords with their devices.

MAUDE Adverse Events (10)

Malfunction

20200328

Malfunction

FDA Classification (59)

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Anesthesiology

Humidifier, Respiratory Gas, (Direct Patient Interface)

Anesthesiology

Anesthesia Conduction Kit

Anesthesiology

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Anesthesiology

High Flow/High Velocity Humidified Oxygen Delivery Device

Anesthesiology

Monitor, Carbon-Dioxide, Cutaneous

Anesthesiology

Plethysmograph, Pressure

Anesthesiology

Caudal Anesthesia Kit

Anesthesiology

Regulator, Pressure, Gas Cylinder

Anesthesiology

Bag, Reservoir

Anesthesiology

Brush, Cleaning, Tracheal Tube

Anesthesiology

Analyzer, Nitrogen Dioxide

Anesthesiology

Algesimeter, Powered

Anesthesiology

Ventilatory Effort Recorder

Anesthesiology

Adjunctive Pain Measurement Device For Anesthesiology

Anesthesiology

Rhinoanemometer (Measurement Of Nasal Decongestion)

Anesthesiology

Cabinet, Table And Tray, Anesthesia

Anesthesiology

Spreader, Cuff

Anesthesiology

Stethoscope, Esophageal

Anesthesiology

Oral Airway Assist

Anesthesiology

Spirometer, Diagnostic

Anesthesiology

Device, Positive Pressure Breathing, Intermittent

Anesthesiology

Sparse Sample Pk Profile And Dosing Software

Anesthesiology

Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)

Anesthesiology

Airway, Oropharyngeal, Anesthesiology

Anesthesiology

Airway, Nasopharyngeal

Anesthesiology

Device Indicating An Exhalation Event

Anesthesiology

Spacer, Direct Patient Interface

Anesthesiology

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Anesthesiology

Apparatus, Gas-Scavenging

Anesthesiology

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Anesthesiology

Circulator, Breathing-Circuit

Anesthesiology

Percussor, Powered-Electric

Anesthesiology

Laryngoscope, Rigid

Anesthesiology

Blood Specimen Collection Kit (Excludes Hiv Testing)

Anesthesiology

Catheter, Nasal, Oxygen

Anesthesiology

Stimulator, Nerve, Ac-Powered

Anesthesiology

Valve, Switching (Ploss)

Anesthesiology

Stool, Anesthesia

Anesthesiology

Analyzer, Gas, Nitrogen, Gaseous-Phase

Anesthesiology

Stimulator, Nerve, Battery-Powered

Anesthesiology

Mask, Oxygen, Non-Rebreathing

Anesthesiology

Vaporizer, Anesthesia, Non-Heated

Anesthesiology

Analyzer, Gas, Neon, Gaseous-Phase

Anesthesiology

Cardiopulmonary Resuscitation Aid Kit

Anesthesiology

Catheters, Suction, Tracheobronchial

Anesthesiology

Spinal Anesthesia Kit

Anesthesiology

Analyzer, Nitrogen Dioxide, Exempt

Anesthesiology

Calibrator, Pressure, Gas

Anesthesiology

Needle, Conduction, Anesthetic (W/Wo Introducer)

Anesthesiology

Protector, Dental

Anesthesiology

Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Anesthesiology

Valve, Non-Rebreathing

Anesthesiology

Monitor, Breathing Frequency

Anesthesiology

Hood, Oxygen, Infant

Anesthesiology

Medevac Use Oxygen Generator

Anesthesiology

Support, Patient Position

Anesthesiology

Strap, Head, Gas Mask

Anesthesiology

Tube, Tracheostomy (W/Wo Connector)

Anesthesiology