CADD 21-2145-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586031342), received between Mar 19, 2018 and Mar 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Charred” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K072144); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2018Charred; Charred

  IT WAS REPORTED THAT CHARRING OCCURRED ON A CADD®-SOLIS POWER CORD USED WITH A MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP. THE PATIENT WAS MOVED TO ANOTHER ROOM. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7350980 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072144. One submission often covers many models, so check the product and lot details in each record.

• Z-1667-2025 · Apr 10, 2025 · Open, Classified
  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 SO
• Z-2419-2024 · Feb 27, 2024 · Open, Classified
  CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximi
• Z-1813-2015 · May 26, 2015 · Terminated
  CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospita
• Z-0166-2015 · Sep 29, 2014 · Terminated
  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
• Z-0004-2012 · May 10, 2011 · Terminated
  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, subcuta
• Z-1033-2011 · Jan 13, 2011 · Terminated
  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-
• Z-1082-2010 · Jan 27, 2010 · Terminated
  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 we