CADD 21-7045-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586020292), received between Jul 31, 2018 and Oct 5, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Device Alarm System1
- Failure to Infuse1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2022Device Alarm System; Failure to Infuse; Device Alarm System; Failure to Infuse
IT WAS REPORTED THAT THE DEVICE HAD AN ALARM WITH STOPPED MESSAGE ON DISPLAY AND ALSO IT WAS REPORTED THAT THE DEVICE WAS NOT INFUSING THE MEDICATION. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15546272 ↗MalfunctionJun 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE USE OF THE CADD EXTENSION SET, THE MEDICATION LEAKED. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Information
MAUDE report 10128137 ↗MalfunctionNov 15, 2019Protective Measures Problem; Protective Measures Problem
INFORMATION RECEIVED A SMITHS MEDICAL CADD EXTENSION SETS WITH VOLUME OF 240 MILLILITERS OF TAXOL WAS INFUSING WHEN HIGH PRESSURE ALARM RANG ALL NIGHT. THE PUMP WAS STOPPED AT 4:00 AM AND WAS SUPPOSE TO INFUSE FOR 27 HOURS. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9331635 ↗MalfunctionJul 31, 2018Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THIS EXTENSION SET EXHIBITED LEAKAGE. IT WAS NOTED THAT THE TUBING HAD NOT COME APART AND THE MEDICATION WAS LEAKING AT THE CONNECTION. THE MEDICAION WAS ALL OVER THE PUMP AND BAG. THE PATIENT WAS NOT HOOKED UP AND THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7736624 ↗
Other Set, administration, intravascular devices
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- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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