CADD 2110 (REF 21-2112-0401-249)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517101041), received between Jan 20, 2022 and Jan 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

4 FDA recall records name this device's identifier, 4 still open.

3 other recalls cover devices cleared under the same FDA submission (K170982); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 10, 2025Open, Classified

   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.

   Z-1667-2025 · Root cause: Labeling design · FDA record ↗

2. Apr 10, 2025Open, Classified

   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.

   Z-1668-2025 · Root cause: Labeling design · FDA record ↗

3. Apr 10, 2025Open, Classified

   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.

   Z-1662-2025 · Root cause: Software design · FDA record ↗

4. Feb 27, 2024Open, Classified

   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.

   Z-2420-2024 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022Infusion or Flow Problem

  THIS IS THE THIRD EVENT WITH SMITH'S MEDICAL CADD SOLIS PCA PUMPS WITH VOLUME INFUSED DISCREPANCIES. CADD PCA PUMP WAS INFUSING HYDROMORPHONE AT 3 MG/HR: 15 ML/HR. RESERVOIR VOLUME AT ZERO. CASSETTE CHANGED. "EMPTY" CARTRIDGE NOTED TO HAVE 29CC OF MEDICATION STILL IN CARTRIDGE DESPITE CADD PUMP AT ZERO . EXTRA MEDICATION WASTED AND DOCUMENTED IN OMNICELL. PHARMACY NOTIFIED. NO PATIENT INJURY. FOLLOW UP INVESTIGATION: BIOMEDICAL ENGINEERING TESTED CADD PUMP POST EVENT AND FOUND NO OPERATIONAL ISSUES. UNABLE TO CONDUCT TESTING WITH ACTUAL PUMP CASSETTE INVOLVED IN EVENT DUE TO THE CONTENTS. FURTHER TESTING WAS CONDUCTED BY BIOMED AND THE TESTING PERFORMED DID NOT FIND ANY DISCREPANCY IN DELIVERY. BIOMED WAS UNABLE TO DUPLICATE ERRORS. UNIT TESTED WITH A 250 ML CASSETTE FILLED WITH RINGERS SOLUTION BY PHARMACY. RAN AT 13 ML/HR. PUMP RAN FOR APPROXIMATELY 19 HRS AND 15 MINS AND TEST RESULTS INDICATED UNIT PERFORMED PROPERLY. ALL FOUR EVENTS OCCURRED ON THE SAME NURSING UNIT. SINCE THE LAST REPORTED EVENT OF JANUARY, NO SIMILAR EVENTS WITH THE PUMP HAVE BEEN REPORTED. DURING THE TIME THESE EVENTS OCCURRED ON THE NURSING UNIT, NURSES WERE REMINDED AT THEIR SHIFT HUDDLES THAT IT IS NOT PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384621 ↗
• MalfunctionJan 28, 2022Infusion or Flow Problem

  THIS IS A FOURTH REPORT OF AN ISSUE WITH THE SMITH'S MEDICAL CADD SOLIS PCA PUMPS WITH VOLUME INFUSED DISCREPANCIES. PATIENT ON PCA DILAUDID. CADD PUMP IN USE AND THE UNIT PLACED A PHARMACY-FILLED 250 ML CASSETTE. RESERVOIR VOLUME AT ZERO. CASSETTE CHANGED (LARGE VOLUME RESERVOIR BEING USED). THIS CARTRIDGE CHECKED FOR RESIDUAL AND NOTED TO HAVE 16 CC OF RESIDUAL MEDICATION STILL IN THE CARTRIDGE. THERE WAS NO INJURY TO THE PATIENT. NEW CADD PUMP ORDERED AND A NEW MEDICATION CARTRIDGE INITIATED. FOLLOW UP INVESTIGATION: BIOMEDICAL ENGINEERING TESTED CADD PUMP POST EVENT AND FOUND NO OPERATIONAL ISSUES. UNABLE TO CONDUCT TESTING WITH ACTUAL PUMP CASSETTE INVOLVED IN EVENT DUE TO THE CONTENTS. FURTHER TESTING WAS CONDUCTED BY BIOMED AND THE TESTING PERFORMED DID NOT FIND ANY DISCREPANCY IN DELIVERY. BIOMED WAS UNABLE TO DUPLICATE ERRORS. UNIT TESTED WITH A 250 ML CASSETTE FILLED WITH RINGERS SOLUTION BY PHARMACY. RAN AT 13 ML/HR. PUMP RAN FOR APPROXIMATELY 19 HRS AND 15 MINS AND TEST RESULTS INDICATED UNIT PERFORMED PROPERLY. ALL FOUR EVENTS OCCURRED ON THE SAME NURSING UNIT. SINCE THE LAST REPORTED EVENT OF JANUARY, NO SIMILAR EVENTS WITH THE PUMP HAVE BEEN REPORTED. DURING THE TIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384620 ↗
• MalfunctionJan 20, 2022Insufficient Flow or Under Infusion; Connection Problem

  PCA CARTRIDGE ALARMED "VOLUME EMPTY", A NEW 250 ML PCA CARTRIDGE WAS HUNG. UPON REMOVING, THE OLD 250 PCA CARTRIDGE A LARGE AMOUNT OF VOLUME REMAINING WAS NOTED AND THE RN NOTED THAT THE PLASTIC COVER OF THE CARTRIDGE WAS NOT COMPLETELY CLOSED. THE RN SHOWED ANOTHER RN AND WHEN LOOKING AT IT, THE CARTRIDGE WAS CLOSED BACK. CHARGE RN WAS UPDATED AND PHARMACIST WAS NOTIFIED AS WELL. TECHNICALLY THE PUMP REPORTED PATIENT RECEIVED ALL 250CC OF NARCOTIC, BUT IF RN WASTED 42CC, THE PATIENT ONLY RECEIVED 208CC ON THE ASSUMPTION THAT PHARMACY DOES NOT OVERFILL THEM. THE OLD PCA CARTRIDGE THAT HAD A LARGE VOLUME REMAINING WAS GIVEN TO THE PHARMACIST IN A SEALED BAG. ADDITIONALLY, THE CADD PCA PUMP WAS SENT DOWN TO BE TESTED FOR PROPER FUNCTIONING. FOLLOW UP: BIOMED REPORTED THE CADD PUMP PASSED TESTING AND WAS PLACED BACK IN SERVICE. PHARMACY REPORTED THAT THEY DO NOT OVERFILL THE CARTRIDGES. THEY ARE PREPPED WITH THE EXACT AMOUNT.

  Patient problems: Insufficient Information

  MAUDE report 13306522 ↗
• MalfunctionJan 20, 2022Output Problem

  PATIENT WAS ON PCA DILAUDID AT 3MG/HR VIA ADD PUMP. RESERVOIR VOLUME AT ZERO. CARTRIDGE CHANGED. REMOVED OLD CARTRIDGE. APPLIED NEW DILAUDID CARTRIDGE 250 CC TOTAL VOLUME. WE ARE USING LARGER RESERVOIR CARTRIDGE DUE TO HIGH RATE. TOTAL VOLUME IS 250CC/CARTRIDGE. THE OLD CARTRIDGE WHICH HAD A ZERO VOLUME ON THE CADD PUMP ACTUALLY HAD ADDITIONAL 44CC OF WASTE NARCOTIC LEFT INSIDE. WRITER WASTED THIS WITH SECOND RN AND DOCUMENTED IN OMNICELL. PHARM CALLED ABOUT POTENTIAL OVERFILL OF CARTRIDGES. PHARM STATES THEY DO NOT OVERFILL PCA CARTRIDGES. CADD PUMP TAKEN OUT OF SERVICE. NURSE QUESTIONING IF THE PUMP NEEDS TO BE RECALIBRATED? BIOMEDICAL ENGINEERING FOLLOW UP: THIS PUMP PASSED OPERATIONAL TESTING WITH NO NOTED ISSUES. SIMILAR EVENT REPORTED ON THIS SAME UNIT/DIFFERENT PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13306521 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170982. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2025 · Apr 10, 2025 · Open, Classified
  CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW,
• Z-0466-2025 · Jun 26, 2024 · Open, Classified
  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
• Z-0963-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8)