CADD 21-7062-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10610586020452), received between Oct 17, 2019 and Jan 17, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2022Failure to Infuse; Failure to Infuse

  INFORMATION WAS RECEIVED INDICATING THAT A PUMP WITH A CADD EXTENSION SET ATTACHED WAS NOT RECOGNIZING A NEW CASSETTE. IT WAS REPORTED THE EVENT OCCURRED AFTER SUCCESSFULLY INFUSING HYDROMORPHONE AND SALINE OVER THE PREVIOUS THREE DAYS WITH A DIFFERENT CASSETTE ATTACHED TO THE PUMP. PER THE CARE MANAGER THE FILLING HOSE OF THE CASSETTE LOOKED DIFFERENT.

  Patient problems: Insufficient Information

  MAUDE report 13265430 ↗
• MalfunctionJan 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING THE USE OF A SMITHS MEDICAL CADD EXTENSION SET, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM THE CONNECTION PART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11120995 ↗
• MalfunctionApr 16, 2020Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE EXTENTION LINE ON THE CADD EXTENSION SET WAS SEVERED. THE PATIENT WENT TO HOSPICE CARE WITH THIS PRODUCT PROBLEM. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968019 ↗
• MalfunctionFeb 4, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD EXTENSION SET MAY HAVE UNDER-INFUSED. IT WAS REPORTED AN UNSPECIFIED AMOUNT OF MEDICAL FLUID REMAINED IN THE CADD MEDICATION CASSETTE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9666673 ↗
• MalfunctionDec 26, 2019Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE, IT WAS NOTED THAT A SMITHS MEDICAL CADD EXTENSION SET SNAPPED APART AND THE PATIENT NOTICED THAT HIS BACKPACK WAS WET. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519980 ↗
• MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD EXTENSION SETS, THE SET SNAPPED APART DURING INFUSION. IT WAS REPORTED THAT THE PUMP WAS IN THE PATIENT'S BACKPACK AND THE BACKPACK GOT WET PRIOR TO THE PATIENT'S MOTHER NOTICED THAT THE INFUSION SETS HAD SNAPPED APART. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9205718 ↗