Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator

• • Ongoing Z-1667-2025 FDA Class I ·initiated 10 Apr 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 injury or death.

• • Ongoing Z-2419-2024 FDA Class I ·initiated 27 Feb 2024

  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.

• • Terminated Z-1813-2015 FDA Class II ·initiated 26 May 2015

  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

• • Terminated Z-0166-2015 FDA Class II ·initiated 29 Sep 2014

  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.

• • Terminated Z-0004-2012 FDA Unclassified (pre-2012) ·initiated 10 May 2011

  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.

• • Terminated Z-1033-2011 FDA Unclassified (pre-2012) ·initiated 13 Jan 2011

  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.

• • Terminated Z-1082-2010 FDA Unclassified (pre-2012) ·initiated 27 Jan 2010

  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.

510(k) Number

K072144 ↗

FDA Product Code

MEA

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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