Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software

• • Ongoing Z-1682-2025 FDA Class I ·initiated 10 Apr 2025

  There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

• • Ongoing Z-1668-2025 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-0222-2025 FDA Class I ·initiated 16 Jul 2024

  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.

• • Ongoing Z-0466-2025 FDA Class II ·initiated 26 Jun 2024 ·on shared 510(k) K111275

  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.

• • Ongoing Z-2421-2024 FDA Class I ·initiated 27 Feb 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 subarachnoid space infusion.

• • Terminated Z-0107-2022 FDA Class I ·initiated 24 Mar 2020

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K111275 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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