CADD 21-6400-51Recalls & reported problems
Icu Medical, Inc. · Class 2
Quick summary
This CADD infusion pump from ICU Medical is used to deliver fluids or medication over time. Reports mostly describe alarms that interrupt infusions, under- or over-delivery of medication, and air bubbles in the tubing. There are 7,541 reports, including 7 deaths and 33 injuries. No recalls name this device. Reports fell to 127 in the last 12 months from 327 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 7,543
- Deaths reported
- 7
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7,543 adverse event reports that list this exact device (DI 10610586019548), received between Apr 17, 2017 and Sep 28, 2026 — classified as 7 deaths, 33 injuries, 7,503 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (3,307 reports).
2 other recalls cover devices cleared under the same FDA submission (K982838); 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.
Reports received per month
Most reported problems
Device problems
- Device Alarm System3,307
- Insufficient Flow or Under Infusion583
- Inaccurate Delivery432
- Output Problem426
- Infusion or Flow Problem403
- Audible Prompt/Feedback Problem364
- Volume Accuracy Problem337
- Excess Flow or Over-Infusion326
Patient problems
- No Clinical Signs, Symptoms or Conditions3,806
- No Patient Involvement1,821
- No Information906
- No Consequences Or Impact To Patient650
- No Known Impact Or Consequence To Patient521
- Insufficient Information514
- Headache24
- Nausea18
Recent adverse event reports
The 25 most recent of 7,543 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925452 ↗MalfunctionSep 22, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859642 ↗MalfunctionSep 17, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809925 ↗MalfunctionSep 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779272 ↗MalfunctionAug 25, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439251 ↗MalfunctionAug 18, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305570 ↗MalfunctionAug 11, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209626 ↗MalfunctionJun 26, 2026Insufficient Flow or Under Infusion; Failure to Infuse
IT WAS REPORTED THAT THE CADD-LEGACY ONE AMBULATORY INFUSION PUMP EXPERIENCED AN NDPWR (NO DISPOSABLE ALARM - PUMP WON'T RUN) ALARM DURING INFUSION, RESULTING IN UNDER-DELIVERY OF 5-FU (5-FLUOROURACIL). THE PATIENT DELAYED REPORTING THE EVENT FOR MORE THAN 8 HOURS, AND NO TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMED RATE WAS 52 ML PER 24 HOURS, AND REMAINING VOLUME WAS 81.5 ML. THERE WERE PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636439 ↗MalfunctionJun 5, 2026Failure to Deliver
IT WAS REPORTED THAT THE PUMP ALARMED WITH A ¿NO DISPOSABLE¿ ALARM DURING USE. THE PATIENT ATTEMPTED TROUBLESHOOTING BY CLAMPING THE TUBING AND REMOVING AND REINSERTING THE CASSETTE TWICE; HOWEVER, THE ALARM PERSISTED, AND AIR BUBBLES WERE NOTED. THE DEVICE WAS REPORTED TO UNDER-DELIVER. THE EVENT OCCURRED WHILE THE DEVICE WAS IN USE WITH A PATIENT IN THE HOME SETTING. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25415102 ↗MalfunctionMay 28, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE PUMP EXHIBITED A NO DISPOSABLE AND CLAMP TUBING ALARM AND UNDER INFUSED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322605 ↗MalfunctionMay 20, 2026Inaccurate Delivery
IT WAS REPORTED THAT THE DEVICE WAS DELIVERING INCORRECT VOLUME IN CONTINUOUS MODE AND IT REQUIRED CALIBRATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229961 ↗MalfunctionMay 19, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE DEVICE HAD INCORRECT VOLUME DELIVERED IN CONTINUOUS MODE AND REQUIRED CALIBRATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216628 ↗MalfunctionMay 18, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE WAS SHOWING LAST ERROR CODE 1871 INDICATING A MOTOR TIMEOUT. PER REPORTER, THE ISSUE WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25202616 ↗MalfunctionMay 11, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE PUMP WAS UNDER INFUSING AND THE SCREEN WAS FAILING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135472 ↗MalfunctionMay 5, 2026Insufficient Flow or Under Infusion
AN EVENT INVOLVING A CADD PUMP WAS REPORTED IN WHICH UNDER DELIVERY WAS IDENTIFIED. THE PUMP WAS PROGRAMMED TO INFUSE 110ML AT A RATE OF 0.6 ML/HOUR AND INDICATED THAT 100.5 ML HAD BEEN DELIVERED WITH 9.5 ML REMAINING. HOWEVER, THE REGISTERED NURSE OBSERVED THAT THE MEDICATION BAG CONTAINED MORE THAN THE INDICATED REMAINING VOLUME. PHARMACY REVIEW CONFIRMED THAT 27.3 ML OF BLINATUMOMAB REMAINED IN THE BAG. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081423 ↗MalfunctionMay 5, 2026Excess Flow or Over-Infusion
AN EVENT INVOLVING A CADD PUMP WAS REPORTED IN WHICH OVER DELIVERY WAS SUSPECTED. THE PATIENT STATED THE PUMP RAN SLOWER THAN PROGRAMMED. BASED ON CALCULATIONS, MORE VOLUME REMAINED THAN EXPECTED AT DISCONNECTION. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081363 ↗MalfunctionMay 5, 2026Collapse
IT WAS REPORTED THAT THE PUMP SHOWS "SERVICE NEEDED MESSAGE" AND HAD A BAD SCREEN. THERE WAS NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081230 ↗MalfunctionMay 4, 2026Device Sensing Problem
IT WAS REPORTED THAT THE PUMP DISPLAYS LAST ERROR CODE 1310. THERE WAS NO PATIENT INVOLVEMENT AND THE ISSUE WAS DISCOVERED DURING TESTING. EVALUATION OF THE RETURNED DEVICE IDENTIFIED A FAULTY DOWNSTREAM OCCLUSION SENSOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070367 ↗MalfunctionMay 4, 2026Failure to Infuse
THE CUSTOMER WAS REPORTED THAT THE DEVICE HAD AN EVENT OF CONSTANT BEEPING DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT/ NO HARM REPORTED. EVALUATION OF THE RETURNED DEVICE IDENTIFIED THE DEFECTIVE DOWNSTREAM OCCLUSION (DSO) SENSOR WHICH MAY LEAD TO INTERRUPTION OF MEDICATION DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069790 ↗MalfunctionApr 21, 2026Improper Flow or Infusion
IT WAS REPORTED THAT THE PUMP EXPERIENCED ERROR CODE 1836 INDICATING A MOTOR FAILURE. PER REPORTER THE BATTERIES WERE REMOVED AND REINSERTED BUT THE ALARM RETURNED. THE DEVICE WAS THEN POWERED OFF. THE PROGRAMMED RATE WAS 4.3 ML PER HOUR, THE REMAINING VOLUME WAS 175.3 ML, AND VOLUME GIVEN WAS 24.7 ML. THE EVENT TOOK PLACE AT THE PATIENT¿S HOME. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940059 ↗MalfunctionApr 17, 2026Improper Flow or Infusion
IT WAS REPORTED THAT THE PUMP SHOWED ERROR CODE 1870 INDICATING A MOTOR TIMEOUT. PER REPORTER, THE SETTINGS WERE ERASED FOLLOWED BY THE SECOND ALARM. THE MEDICATION WAS INFUSED AT RATE OF 2.2 ML PER HOUR. THE REMAINING VOLUME WAS 73.6 AND GIVEN VOLUME WAS 25 ML. THE EVENT OCCURRED DURING INFUSION AT THE PATIENT'S HOME. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916513 ↗MalfunctionApr 17, 2026Volume Accuracy Problem
IT WAS REPORTED THAT THE DEVICE HAD INCORRECT VOLUME DELIVERED IN CONTINUOUS MODE REQUIRES CALIBRATION. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912161 ↗MalfunctionApr 17, 2026Volume Accuracy Problem
IT WAS REPORTED THAT THE DEVICE HAD INCORRECT VOLUME DELIVERED IN CONTINUOUS MODE REQUIRES CALIBRATION. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912147 ↗MalfunctionApr 17, 2026Volume Accuracy Problem
IT WAS REPORTED THAT THE DEVICE HAD INCORRECT VOLUME DELIVERED IN CONTINUOUS MODE REQUIRES CALIBRATION. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912135 ↗MalfunctionApr 17, 2026Volume Accuracy Problem
IT WAS REPORTED THAT THAT THE DEVICE HAD INCORRECT VOLUME DELIVERED IN CONTINUOUS MODE REQUIRES CALIBRATION. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912118 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982838. One submission often covers many models, so check the product and lot details in each record.
- Z-0307-2018 · Nov 22, 2017 · TerminatedCADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
- Z-1235-2010 · Dec 23, 2009 · TerminatedCADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.