CADD 21-7091-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10610586024160), received between Jul 13, 2017 and Aug 11, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DISPOSABLE EXHIBITED A LEAK AT THE CONNECTION WHERE THE PCA LINE JOINS THE PRIMARY LINE. NURSE NOTED AIR IN LINE. NURSE DISCONNECTED THE LINE FROM THE PATIENT TO ATTEMPT TO FLUSH THE AIR THROUGH. WHEN FLUSHED FROM THE PRIMARY LINE THE FLUSH CONTINUED TO THE END OF THE LINE, BUT THEN DRAINED BACK TO THE CONNECTION WHERE THE PCA LINE JOINS AND BEGAN TO LEAK. PATIENT WAS NEWLY FEBRILE BUT STABLE, UNKNOWN IF RELATED. PATIENT WAS FULLY CULTURED AND THE DEFECTIVE LINE AND IJ REMOVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Fever

  MAUDE report 17514656 ↗
• MalfunctionApr 25, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRODUCT WAS UNDER INFUSING, DOES NOT PASS ACCURACY TEST; IT IS UNCERTAIN OF THE CAUSE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812277 ↗
• MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PUMP TUBING WAS FOUND TO BE LEAKING AT THE Y-SITE JUNCTION. THE PATIENT MAY HAVE RECEIVED LESS MEDICATION THAN INTENDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396091 ↗
• MalfunctionAug 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT UPON DISCONNECTING THE DISTAL END OF THE Y-PORT, THE REMAINING CONNECTION LEAKED AS IT WAS CONNECTED TO THE PATIENT'S CANNULA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15184367 ↗
• MalfunctionAug 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT UPON DISCONNECTING THE DISTAL END OF THE Y-PORT, THE REMAINING CONNECTION LEAKED AS IT WAS CONNECTED TO THE PATIENT'S CANNULA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15169393 ↗
• MalfunctionAug 4, 2022Crack; Crack

  IT WAS REPORTED THAT DURING USE THE DEVICE BEGAN LEAKING ON THE FLOOR AND BLOOD WAS BACKING UP IN THE PROXIMAL PORT. THE CONNECTION BETWEEN THE TUBING AND RUNNER LINE WAS CRACKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164109 ↗
• MalfunctionJul 13, 2017Leak/Splash; Delamination; Infusion or Flow Problem; Leak/Splash; Delamination; Infusion or Flow Problem

  IT WAS REPORTED THAT BEFORE CHANGING THE PERFUSION BAG, AIR BUBBLES WERE PRESENT IN THE TUBING OF A CADD® ADMINISTRATION SET. THE FAULT WAS NOTICED WHEN THE PUMP ALARMED AND DISPLAYED THE MESSAGE: "AIR BUBBLES IN TUBE". THE TUBING WAS PURGED, BUT THE BUBBLES THEN APPEARED IN THE CASSETTE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711882 ↗
• MalfunctionJul 13, 2017Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BEFORE CHANGING THE PERFUSION BAG, AIR BUBBLES WERE PRESENT IN THE TUBING OF A CADD ADMINISTRATION SET. THE FAULT WAS NOTICED WHEN THE PUMP ALARMED AND DISPLAYED THE MESSAGE: "AIR BUBBLES IN TUBE". THE TUBING WAS PURGED, BUT THE BUBBLES THEN APPEARED IN THE CASSETTE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711879 ↗
• MalfunctionJul 13, 2017Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BEFORE CHANGING THE PERFUSION BAG, AIR BUBBLES WERE PRESENT IN THE TUBING OF A CADD® ADMINISTRATION SET. THE FAULT WAS NOTICED WHEN THE PUMP ALARMED AND DISPLAYED THE MESSAGE: "AIR BUBBLES IN TUBE". THE TUBING WAS PURGED, BUT THE BUBBLES THEN APPEARED IN THE CASSETTE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711876 ↗