CADD 21-7381-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 10610586027468), received between Apr 4, 2018 and Feb 6, 2026 — classified as 135 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (41 reports).

3 other recalls cover devices cleared under the same FDA submission (K031361); 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 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT LEAK FROM THE AREA WHERE THE TUBING CONNECTED TO THE BAG. THERE WAS A PATIENT INVOLVEMENT BUT, THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277051 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING HAD BEEN LEAKING AT THE CONNECTION POINT OF THE CASSETTE OVER THE PAST SEVERAL WEEKS. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733869 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING HAD BEEN LEAKING AT THE CONNECTION POINT OF THE CASSETTE OVER THE PAST SEVERAL WEEKS. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733868 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING HAD BEEN LEAKING AT THE CONNECTION POINT OF THE CASSETTE OVER THE PAST SEVERAL WEEKS. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733726 ↗
• MalfunctionJun 13, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE PATIENT HAD BEEN COMPLAINING ABOUT THE HIGH-PRESSURE ALARM GOING OFF ABOUT FOUR HOURS AFTER INFUSING. THE OUTCOME OF THE EVENT WAS ONGOING. THE PATIENT EXPERIENCED 2-3 BAGS PER WEEK THAT TRIGGERED THE HIGH-PRESSURE ALARM. PUMPS WERE SWAPPED SEVERAL TIMES, CONFIRMING THAT THE PUMP WAS NOT THE ISSUE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207315 ↗
• MalfunctionJun 13, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A PATIENT EXPERIENCED THE CONTENTS OF THEIR BAG RUNNING EMPTY BEFORE THE INTENDED TIME. THE THERAPIES RANGED FROM TPNS WITH TAPER DOSING TO POST-CHEMO HYDRATION WITH CONTINUOUS INFUSIONS, WITH THE INFUSIONS ENDING AS EARLY AS AN HOUR TO THREE HOURS BEFORE THE EXPECTED TIME. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206922 ↗
• MalfunctionJun 13, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE PATIENT HAD BEEN COMPLAINING ABOUT THE HIGH-PRESSURE ALARM GOING OFF ABOUT FOUR HOURS AFTER INFUSING. THE OUTCOME OF THE EVENT WAS ONGOING. THE PATIENT EXPERIENCED 2-3 BAGS PER WEEK THAT TRIGGERED THE HIGH-PRESSURE ALARM. PUMPS WERE SWAPPED SEVERAL TIMES, CONFIRMING THAT THE PUMP WAS NOT THE ISSUE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206860 ↗
• MalfunctionJun 13, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A PATIENT EXPERIENCED THE CONTENTS OF THEIR BAG RUNNING EMPTY BEFORE THE INTENDED TIME. THE THERAPIES RANGED FROM TPNS WITH TAPER DOSING TO POST-CHEMO HYDRATION WITH CONTINUOUS INFUSIONS, WITH THE INFUSIONS ENDING AS EARLY AS AN HOUR TO THREE HOURS BEFORE THE EXPECTED TIME. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206808 ↗
• MalfunctionJun 13, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A PATIENT EXPERIENCED THE CONTENTS OF THEIR BAG RUNNING EMPTY BEFORE THE INTENDED TIME. THE THERAPIES RANGED FROM TPNS WITH TAPER DOSING TO POST-CHEMO HYDRATION WITH CONTINUOUS INFUSIONS, WITH THE INFUSIONS ENDING AS EARLY AS AN HOUR TO THREE HOURS BEFORE THE EXPECTED TIME. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206665 ↗
• MalfunctionMay 13, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE DEVICE HAD NOT COMPLETELY FOLLOWED THE PUMP'S DIRECTIONS AND HAD INFUSED MORE THAN WHAT THE PUMP HAD INDICATED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014160 ↗
• MalfunctionJun 14, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL COMPLAINTS FROM PATIENTS ABOUT THEIR INFUSION BAGS RUNNING OUT BEFORE THE SCHEDULED TIMES AND THAT THE PROBLEM MAY BE WITH THE TUBING. THE CASSETTE DELIVERED 54 ML AFTER PROGRAMMING FOR 50 ML. THESE DID NOT MEET A +/-6% THRESHOLD. ALL WERE TESTED WITH THE SAME PUMP, WHICH WHEN SENT IN FOR PREVENTATIVE MAINTENANCE, WAS CERTIFIED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127467 ↗
• MalfunctionMay 9, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT THE TUBING WAS DISCOLORED (BROWN) AND THAT TOWARD THE END OF THE INFUSION IT WAS PULLING AIR. WHEN THE STOCK WAS CHECKED, THE PACKAGING AND THE TUBING APPEARED TO BE DISCOLORED. THE CUSTOMER HAS STORED THE ITEM APPROPRIATELY AND PACKAGING APPEARS TO BE INTACT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896611 ↗
• MalfunctionMay 5, 2023Material Discolored; Product Quality Problem; Air/Gas in Device; Material Discolored; Product Quality Problem; Air/Gas in Device

  IT WAS REPORTED THE DISPOSABLE WAS DISCOLORED AND AT THE END OF THE INFUSION IT WAS PULLING AIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876917 ↗
• MalfunctionJun 6, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THE PATIENT IS RUNNING INTO AN ISSUE WHERE HE IS DOWN TO THE LAST TUBING FOR THE CADD SOLIS PUMP. PURCHASED A NEW SET BUT THE PUMP ERRORS OUT. CUSTOMER IS NOT SENDING BACK THE PRODUCT AND ASKED THIS CASE TO BE CLOSE SINCE HE'LL WORK WITH OTHER SUPPLIERS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600622 ↗
• MalfunctionSep 2, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THE DEVICE WAS IN USE FOR INFUSION OF PARENTERAL NUTRITION. THE USER FACILITY STATED THE IV BAG WAS FILLED WITH 1632 ML (INTENDED TO BE INFUSED) AND 100 ML OVERFILL. THE REPORTER STATED THE INFUSION ENDED AND MORE FLUID HAD BEEN ADMINISTERED THAN WAS PROGRAMMED. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414757 ↗
• MalfunctionJun 11, 2020Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET TUBING GOT DETACHED DURING THE ADMINISTRATION OF TOTAL PARENTERAL NUTRITION (TPN). THE END OF THE ADMINISTRATION SET FELL OFF. THERE WAS NO REPORTED ADVERSE EVENT.

  Patient problems: No Information

  MAUDE report 10142958 ↗
• MalfunctionJun 11, 2020Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET TUBING GOT DETACHED DURING THE ADMINISTRATION OF TOTAL PARENTERAL NUTRITION (TPN). THE END OF THE ADMINISTRATION SET FELL OFF. THERE WAS NO REPORTED ADVERSE EVENT.

  Patient problems: No Information

  MAUDE report 10142951 ↗
• MalfunctionJun 11, 2020Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET TUBING GOT DETACHED DURING THE ADMINISTRATION OF TOTAL PARENTERAL NUTRITION (TPN). THE END OF THE ADMINISTRATION SET FELL OFF. THERE WAS NO REPORTED ADVERSE EVENT.

  Patient problems: No Information

  MAUDE report 10142901 ↗
• MalfunctionJun 10, 2020Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET TUBING GOT DETACHED DURING THE ADMINISTRATION OF TOTAL PARENTERAL NUTRITION (TPN). THE END OF THE ADMINISTRATION SET FELL OFF. THERE WAS NO REPORTED ADVERSE EVENT.

  Patient problems: No Information

  MAUDE report 10140870 ↗
• MalfunctionJun 10, 2020Leak/Splash; Material Separation; Leak/Splash; Material Separation

  INFORMATION RECEIVED A SMITHS MEDICAL CADD ADMINISTRATION SETS - FLOW STOP WAS INFUSING TPN DURING THE NIGHT AND FOUND THE TUBING HAD CAME APART. THE (B)(6) YEAR OLD PATIENT DID NOT SUFFER ANY HARM. UNCLEAR IF THE PRODUCT CAME APART ON ITS OWN OR PERHAPS THE PATIENT PULLED ON THE TUBING. ALSO WONDERING IF ADHESIVE IS COMING APART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140157 ↗
• MalfunctionJun 10, 2020Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET TUBING GOT DETACHED DURING THE ADMINISTRATION OF TOTAL PARENTERAL NUTRITION (TPN). THE END OF THE ADMINISTRATION SET FELL OFF. THERE WAS NO REPORTED ADVERSE EVENT.

  Patient problems: No Information

  MAUDE report 10139102 ↗
• MalfunctionJun 9, 2020Leak/Splash; Material Separation; Leak/Splash; Material Separation

  INFORMATION RECEIVED A SMITHS MEDICAL CADD ADMINISTRATION SETS - FLOW STOP WAS INFUSING TPN DURING THE NIGHT AND FOUND THE TUBING HAD CAME APART. THE (B)(6) YEAR OLD PATIENT DID NOT SUFFER ANY HARM. PHOTOS ARE ATTACHED TO SHOW DAMAGE. UNCLEAR IF THE PRODUCT CAME APART ON ITS OWN OR PERHAPS THE PATIENT PULLED ON THE TUBING. ALSO WONDERING IF ADHESIVE IS COMING APART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136171 ↗
• MalfunctionJun 9, 2020Leak/Splash; Material Separation; Leak/Splash; Material Separation

  INFORMATION RECEIVED A SMITHS MEDICAL CADD ADMINISTRATION SETS - FLOW STOP WAS INFUSING TPN DURING THE NIGHT AND FOUND THE TUBING HAD CAME APART. THE (B)(6) YEAR OLD PATIENT DID NO SUFFER ANY HARM. PHOTOS ARE ATTACHED TO SHOW DAMAGE. UNCLEAR IF THE PRODUCT CAME APART ON ITS OWN OR PERHAPS THE PATIENT PULLED ON THE TUBING. ALSO WONDERING IF ADHESIVE IS COMING APART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136100 ↗
• MalfunctionJun 9, 2020Leak/Splash; Material Separation; Leak/Splash; Material Separation

  INFORMATION RECEIVED A SMITHS MEDICAL CADD ADMINISTRATION SETS - FLOW STOP WAS INFUSING TPN DURING THE NIGHT AND FOUND THE TUBING HAD CAME APART. THE 11 YEAR OLD PATIENT DID NOT SUFFER ANY HARM. PHOTOS SHOW DAMAGE. UNCLEAR IF THE PRODUCT CAME APART ON ITS OWN OR PERHAPS THE PATIENT PULLED ON THE TUBING. ALSO WONDERING IF ADHESIVE IS COMING APART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136075 ↗
• MalfunctionJun 9, 2020Break; No Flow; Break; No Flow

  INFORMATION RECEIVED CADD ADMINISTRATION SETS - FLOW STOP BROKEN TUBING AT LUER LOCK.. PHOTOS PROVIDED AND NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10133282 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031361. One submission often covers many models, so check the product and lot details in each record.

• Z-0962-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
• Z-0148-2022 · Jul 14, 2020 · Terminated
  CADD Administration Sets, Model #21-7346-24
• Z-2589-2017 · May 15, 2017 · Terminated
  CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid