CADD 21-7109-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10610586034497), received between Jul 31, 2018 and Aug 8, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ADMINISTRATION OF CHEMOTHERAPY THE MEDICATION CAME OUT OF THE FILTER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183524 ↗
• MalfunctionAug 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ADMINISTRATION OF CHEMOTHERAPY THE MEDICATION CAME OUT OF THE FILTER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176722 ↗
• MalfunctionMar 18, 2021Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD EXTENSION SET HAD BROKEN OFF AND FOUND SEPARATED IN BED. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516562 ↗
• MalfunctionMar 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD EXTENSION SETS, FLUID LEAKED AT THE FILTER WAS NOTED. IT WAS REPORTED THAT THE DEVICE WAS IN USE WITH PATIENT FOR INFUSION OF VELETRI. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453795 ↗
• MalfunctionMar 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD EXTENSION SETS, FLUID LEAKED AT THE FILTER WAS NOTED. IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THE "HOSPITAL TO RECEIVE ADDITIONAL MEDICATION WITH A CRISIS AS PER INSUFFICIENT TREATMENT DUE TO FLUID LEAKAGE". ACCORDING TO THE REPORT, THE DEVICE WAS IN USE WITH PATIENT FOR INFUSION OF VELETRI. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453790 ↗
• MalfunctionMar 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD EXTENSION SETS, FLUID LEAKED AT THE FILTER WAS NOTED. IT WAS REPORTED THAT THE DEVICE WAS IN USE WITH PATIENT FOR INFUSION OF VELETRI. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453788 ↗
• MalfunctionMar 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD EXTENSION SETS, FLUID LEAKED AT THE FILTER WAS NOTED. IT WAS REPORTED THAT THE DEVICE WAS IN USE WITH PATIENT FOR INFUSION OF VELETRI. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453782 ↗
• MalfunctionJul 31, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CADD EXTENSION SET HAD OVERINFUSED. THE PROGRAMMED SETTINGS WERE 2ML/ HR, WITH A TOTAL VOLUME OF 90 ML OVER 46 HOURS. 10 ML WERE REPORTEDLY REMAINING. TUBING WAS NOTED TO HAVE DISCONNECTED FROM 100 ML CASSETTE. NO PATIENT INJURY RESULTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7736744 ↗