CADD 21-7022-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10610586019791), received between Jun 8, 2017 and Sep 28, 2026 — classified as 67 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (31 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924335 ↗
• MalfunctionSep 25, 2026Fluid/Blood Leak

  It was reported that the doctor opened the packaging and found that the CADD admin set's area where the tubing connects to the blood stool pump was leaking. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896936 ↗
• MalfunctionSep 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722451 ↗
• MalfunctionMar 6, 2026Insufficient Flow or Under Infusion; Failure to Infuse; Air/Gas in Device

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET TRIGGERED AN AIR IN LINE ALARM. A CONSIDERABLE AMOUNT OF AIR WAS DETECTED IN THE LINE. THE PUMP HAD BEEN DELIVERING A CONTINUOUS INFUSION RATE OF 22.5 ML PER HOUR, WITH THE RESERVOIR STARTING AT 540 ML AND THE REMAINING VOLUME STILL 540 ML. THE PATIENT WAS NOT MEDICALLY HARMED; HOWEVER, THE FULL PRESCRIBED DOSE WAS NOT ADMINISTERED. THIS EVENT OCCURRED WHILE THE DEVICE WAS IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533134 ↗
• MalfunctionFeb 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT¿S TUBING HAD A LEAK. THE EXACT LOCATION OF THE LEAK HAD NOT BEEN DETERMINED. THE TUBING HAD BECOME DISCONNECTED FROM THE PATIENT. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401211 ↗
• MalfunctionFeb 10, 2026Leak/Splash

  IT WAS REPORTED THAT THE TUBING HAD BEEN FOUND BROKEN APPROXIMATELY 6 INCHES BELOW THE CONNECTION CLOSEST TO THE PORT, AND CHEMOTHERAPY HAD BEEN OBSERVED LEAKING FROM THE SITE. THE PUMP HAD BEEN POWERED OFF, AND THE CLAMP NEAREST THE PORT HAD BEEN CLOSED. CHEMOTHERAPY SPILL INSTRUCTIONS HAD BEEN REVIEWED, AND THE PATIENT HAD BEEN ADVISED TO CALL THE PHYSICIAN CLINIC IMMEDIATELY PER SFI. IT HAD BEEN REPORTED BY THE CHEMOTHERAPY NURSE THAT THE LEAK WAS LOCATED A COUPLE OF INCHES AWAY FROM WHERE THE TUBING HAD BEEN ATTACHED TO THE PUMP. THERE WAS NO INJURY. THE MEDICATION HAD BEEN 5-FU. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308882 ↗
• MalfunctionDec 15, 2025Complete Blockage; Disconnection; Complete Blockage; Disconnection

  IT WAS REPORTED THAT THE DEVICES¿ TUBING WAS DISCONNECTED. THE REPORTER NOTED THAT WHEN THE PATIENT WOKE UP IN THE MORNING, THE TUBING HAD BEEN FOUND DISCONNECTED. THE DISCONNECTION HAD OCCURRED AT THE BLUE CONNECTOR ON THE TUBING FROM THE PUMP. THE PUMP HAD BEEN ALARMING WITH A ¿DOWNSTREAM OCCLUSION¿ MESSAGE. THE PATIENT HAD BEEN INSTRUCTED TO STOP THE PUMP AND CLAMP THE TUBING. IT HAD BEEN EXPLAINED THAT ANY TUBING THAT BECAME DISCONNECTED COULD NOT BE RECONNECTED. THE PATIENT HAD BEEN INSTRUCTED TO CONTACT THE CLINIC FOR FURTHER INSTRUCTIONS AND HAD BEEN REMINDED OF THE FOUR-HOUR STOP WINDOW. THE PATIENT HAD BEEN UNSURE HOW LONG THE PUMP HAD BEEN DISCONNECTED DURING SLEEP. THE CLINIC HAD BEEN SCHEDULED TO OPEN AT 8:00 A.M., AND THE PATIENT HAD STATED AN INTENTION TO ARRIVE AT THAT TIME BUT HAD BEEN ADVISED TO CALL IMMEDIATELY DUE TO THE MEDICATION STOP WINDOW. THE SPIROS HAD REMAINED CONNECTED TO THE ADMINISTRATION SET, WHICH HAD CAUSED THE DOWNSTREAM OCCLUSION ALARM AND PREVENTED ANY LEAK AFTER THE DISCONNECTION. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. ASSOCIATED PUMP COMPLAINT DOCUMENTED ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804238 ↗
• MalfunctionSep 3, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD ALARMED AIR IN LINE. PHOTOGRAPHS FROM THE PHARMACY HAD SHOWN NO AIR BUBBLES IN THE BAG AT THE TIME OF COMPOUNDING. THE CONTINUOUS INFUSION RATE HAD BEEN SET AT 22 ML/HR, WITH A RESERVOIR VOLUME OF 378 ML. A TOTAL OF 146 ML HAD BEEN ADMINISTERED. BOTH THE AIR DETECTOR AND THE UPSTREAM SENSOR HAD BEEN TURNED ON. THE LENGTH OF INFUSION HAD BEEN PROGRAMMED FOR 24 HOURS, AND THE LOCK LEVEL HAD BEEN LOCKED. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING. INSTEAD, THE TUBING HAD BEEN PRIMED MANUALLY, AND A REPEATER PUMP HAD BEEN USED TO ADD THE VOLUME TO THE BAG. THERE HAD BEEN NO APPARENT MEDICAL EFFECTS ON THE PATIENT, ALTHOUGH THE FULL DOSE HAD NOT BEEN RECEIVED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952116 ↗
• MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S TUBING WAS LEAKING AT THE CONNECTION BETWEEN THE MEDICATION TUBING AND THE PORT TUBING. A CONNECTOR WAS PRESENT BUT HAD BEEN TAPED, AND THE TAPE WAS SOAKED. THE PUMP WAS STOPPED, AND THE TUBING WAS CLAMPED ABOVE AND BELOW THE LEAK. TROUBLESHOOTING WAS PERFORMED, BUT THE LEAK PERSISTED. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951878 ↗
• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A BLOOD AND 5-FU CHEMOTHERAPY HAD BEEN LEAKING FROM THE PATIENT¿S CONTINUOUS IV PUMP. THE LEAK HAD BEEN STATED TO ORIGINATE FROM THE CONNECTION. THE PATIENT HAD BEEN ADVISED TO RETURN THE PUMP TO THE INFUSION SITE UPON DISCHARGE. THE TUBING HAD LIKELY BEEN DISPOSED OF. THE CONTINUOUS INFUSION HAD BEEN INITIATED ON (B)(6) 2025 WITH A TOTAL RESERVOIR VOLUME OF 138 ML, ADMINISTERED AT A RATE OF 3 ML/HR OVER A 46-HOUR PERIOD; THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING, AS THE LINE HAD BEEN MANUALLY PRIMED USING A SYRINGE, AND THE PATIENT HAD SUBSEQUENTLY BEEN ADVISED TO VISIT THE EMERGENCY ROOM AND WAS ADMITTED FOR MONITORING DUE TO SKIN IRRITATION. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22564910 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKS OCCURRED WHERE THE CLOSED SYSTEM TRANSFER DEVICE (CSTD) WAS ATTACHED TO THE PURPLE LUER LOCK CONNECTOR OF THE CADD TUBING. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207019 ↗
• MalfunctionMar 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING EXHIBITED A LEAKAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677791 ↗
• MalfunctionMar 5, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING WAS DISCONNECTED AT A CONNECTOR BECAUSE THE BLUE PIECE THAT PROTECTS IT KEPT POPPING OFF. IT HAD BEEN ATTEMPTED TO RECONNECT THE TUBING AND RESTART THE PUMP BUT A "DOWNSTREAM OCCLUSION" ALARM WAS DISPLAYED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529677 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DEFECT/ERROR WITH A CADD ADMINISTRATION SET THAT LEAD TO CHEMOTHERAPY LEAKING PRIOR TO ADMINISTRATION. THE PHARMACY STAFF REVIEWED TWO ADDITIONAL CADD ADMINISTRATION SETS AND THE SAME THING HAPPENED TO THOSE - THAT THE TUBING SEPARATES FROM THE PLASTIC BASE QUITE EASILY, WHICH COULD RESULT IN LEAKAGE. THE EVENT OCCURRED PRIOR TO ADMINISTRATION. IT IS UNKNOWN IF THE PRODUCT IS AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337209 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DEFECT/ERROR WITH A CADD ADMINISTRATION SET THAT LEAD TO CHEMOTHERAPY LEAKING PRIOR TO ADMINISTRATION. THE PHARMACY STAFF REVIEWED TWO ADDITIONAL CADD ADMINISTRATION SETS AND THE SAME THING HAPPENED TO THOSE - THAT THE TUBING SEPARATES FROM THE PLASTIC BASE QUITE EASILY, WHICH COULD RESULT IN LEAKAGE. THE EVENT OCCURRED PRIOR TO ADMINISTRATION. IT IS UNKNOWN IF THE PRODUCT IS AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337207 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DEFECT/ERROR WITH A CADD ADMINISTRATION SET THAT LEAD TO CHEMOTHERAPY LEAKING PRIOR TO ADMINISTRATION. THE PHARMACY STAFF REVIEWED TWO ADDITIONAL CADD ADMINISTRATION SETS AND THE SAME THING HAPPENED TO THOSE - THAT THE TUBING SEPARATES FROM THE PLASTIC BASE QUITE EASILY, WHICH COULD RESULT IN LEAKAGE. THE EVENT OCCURRED PRIOR TO ADMINISTRATION. IT IS UNKNOWN IF THE PRODUCT IS AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337196 ↗
• MalfunctionDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PACKAGE WAS OPENED, INSTALLED, AND THE PRODUCT WAS FOUND TO BE LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20837547 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PACKAGE WAS OPENED, INSTALLED, AND THE PRODUCT WAS FOUND TO BE LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801690 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE OF THE DEVICE AND INSTALLING IT, IT WAS FOUND THAT THE PRODUCT WAS LEAKING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791430 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT AFTER OPENING THE PACKAGE OF THE DEVICE AND INSTALLING IT. IT WAS FOUND, THAT THE PRODUCT WAS LEAKING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789688 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT AFTER OPENING THE PACKAGE OF THE DEVICE AND INSTALLING IT. IT WAS FOUND, THAT THE PRODUCT WAS LEAKING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788046 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE OF THE DEVICE AND INSTALLING IT, IT WAS FOUND THAT THE PRODUCT WAS LEAKING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787802 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PACKAGE WAS OPENED, INSTALLED, AND THE PRODUCT WAS FOUND TO BE LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778809 ↗
• MalfunctionNov 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PACKAGE WAS OPENED, INSTALLED, AND THE PRODUCT WAS FOUND TO BE LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776619 ↗
• MalfunctionNov 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PRODUCT WAS FOUND TO BE LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774939 ↗