Cadd -Solis Ambulatory Infusion Pump, Version 3.0

• • 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.

• • 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

510(k) Number

K130394 ↗

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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• What is the CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 used for?

  The CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 is designed for delivering controlled, precise doses of fluids or medications in outpatient or ambulatory settings. It supports a range of therapeutic applications, including patient-controlled analgesia (PCA) and continuous infusion therapies, providing flexibility for various clinical needs such as pain management or medication administration outside of traditional hospital environments.

• Is the CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 intended for single-use or reuse?

  This device is explicitly intended for single-use only. Its sterile packaging ensures safety and reliability for one-time patient use, reducing the risk of contamination or cross-infection. Reuse is not recommended or supported by the manufacturer to maintain sterility and functionality as outlined in the device’s regulatory and operational guidelines.

• How is the CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 supplied, and what sterility assurances does it provide?

  The CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 is supplied sterile in its original packaging. This ensures that the device meets the necessary hygiene standards for direct patient use without additional sterilization procedures. The manufacturer’s guidelines emphasize maintaining sterility during storage and handling to preserve the device’s integrity for its intended single-use application.

• What regulatory pathway does the CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 follow, and what standards does it adhere to?

  The device is regulated under the FDA 510(k) clearance pathway, specifically classified as substantially equivalent to predicate devices under 21 CFR 880.5725. It received clearance with the K130394 number and is intended for use in general hospital settings. The regulatory process confirms its compliance with safety and performance standards for infusion pumps, ensuring it meets the requirements for outpatient and ambulatory use.

• Can the CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 be used in an MRI environment?

  No, the CADD-SOLIS Ambulatory Infusion Pump, Version 3.0 is not MRI-compatible. This means it should not be used or stored near MRI machines, as exposure to magnetic fields could compromise its functionality or pose safety risks. Clinicians must ensure the device is placed in a non-MRI environment to avoid interference or damage.