CADD 21-7061-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10610586020445), received between Apr 13, 2018 and Jul 2, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DRUG LEAKED. THIS OCCURRED DURING USE IN (B)(6) 2025. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382977 ↗
• MalfunctionJun 16, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A VISIT TO EXCHANGE THE CASSETTE, THERE WAS A LEAK DUE TO A CRACK IN THE TUBE, AND THE MEDICATION WAS NOT BEING INJECTED INTO THE PATIENT. THE EVENT OCCURRED DURING USE, AND THE SITUATION WAS ADDRESSED AS THE PATIENT WAS COMPLAINING OF SEVERE PAIN DURING THE VISIT.

  Patient problems: Pain

  MAUDE report 22211982 ↗
• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER FILLING THE CASSETTE, LIQUID LEAKAGE WAS DETECTED. IT WAS REPORTED THAT THERE WAS A DELAY IN SUPPLYING THE PATIENT, BUT NO THERAPY-RELEVANT DELAY. THE EVENT TOOK PLACE AT THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627191 ↗
• MalfunctionSep 20, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268018 ↗
• MalfunctionMay 10, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BLOCKAGE ALARM SOUNDED AND UPON CHECKING, AND THE LINE WAS BLOCKED AND CRYSTALLIZED. THIS OCCURRED TWO SEPARATE TIMES. THIS OCCURRED DURING PATIENT USE, AND THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286452 ↗
• MalfunctionApr 12, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THE DISPOSABLE CAUSED THE DEVICE TO EXHIBIT AN OBSTRUCTION ALARM - WITH NO CAUSE. PER REPORTER THE ALARM SOUNDS EVEN AFTER A SUBCUTANEOUS PUNCTURE, BUT IT IS LESS LIKELY TO SOUND IF THE PUMP IS RAISED TO A HIGHER LEVEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101294 ↗
• MalfunctionJul 20, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THE DISPOSABLE EXHIBITED AN OBSTRUCTION DURING INFUSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367834 ↗
• MalfunctionDec 29, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT AN ERROR MESSAGE AND ALARM GO OFF. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL BY THE MANUFACTURER ON 08-DEC-2022 AND ATTACHED TO COMPLAINT OBJECT. A CASSETTE WAS CONNECTED TO AN EXTENSION HOSE. THE CASSETTE WAS FILLED WITH MORPHINE, KETAMINE, MIDAZOLAM AND SODIUM CHLORIDE. THE CASSETTE WAS FILLED AT THE USERS SIDE (B)(6) 2022 AND THE PALLIATIVE TEAM SHOULD CONNECT THE CASSETTE TO THE PUMP ON (B)(6) 2022. BY CONNECTING THE CASSETTE TO THE PUMP, ERRORS AND AN ALARM ACCRUED. THE CASSETTE WAS TRIED TO BE CONNECTED TO OTHER PUMPS, BUT WITH THE SAME RESULT. EVENTUALLY THE PUMP WAS STARTED, BUT WITH SO MANY ALARMS, THAT THEY HAD TO FILL A NEW CASSETTE THE NEXT DAY WITH A NEW BATCH INSTEAD AND THIS BATCH WORKED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069539 ↗
• MalfunctionFeb 21, 2022Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED INDICATING THAT DURING PRE-USE CHECK A PUMP USING A CADD EXTENSION SET WAS UNABLE TO PASS MEDICAL FLUID THROUGH THE PRODUCT. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13568685 ↗
• MalfunctionMay 5, 2021Excess Flow or Over-Infusion; Infusion or Flow Problem; Excess Flow or Over-Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD CASSETTE RESERVOIRS, OVER DELIVER OF MEDICAL FLUID WAS OBSERVED. IT WAS REPORTED THAT THE CUSTOMER ESTIMATED SOME AMOUNT OF MEDICAL FLUID WAS SUPPOSED TO REMAIN IN THE CASSETTE; HOWEVER, NONE WAS FOUND IN IT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775056 ↗
• MalfunctionSep 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL ADMINISTRATION SET WAS LEAKING WHEN CONNECTED TO A THREE-WAY STOPCOCK AS THE CUSTOMER ATTEMPTED TO INFUSE MEDIAL FLUID (PHYSIOLOGICAL SALINE SOLUTION) USING A SYRINGE BEFORE USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482775 ↗
• MalfunctionOct 2, 2019Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL FLEX TUBING WHEN USING A CADD LEGACY PUMP FOUND THAT THE TUBING WAS WET. IT WAS DISCOVERED THAT THE TUBE WAS CROOKED AND ONLY HELD AT THE END OF THE CONNECTOR. THERE WAS NO REPORTED ADVERSE EVENTS DUE TO THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145597 ↗
• MalfunctionAug 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT AFTER FIVE HOURS OF USE OF THE SMITHS MEDICAL CADD EXTENSION SET, IT WAS NOTED THAT THE CONNECTION POINT WAS LEAKING. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8912833 ↗
• MalfunctionApr 13, 2018Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED INDICATING THAT A CADD® EXTENSION SETS ATTACHED TO A SMITHS MEDICAL CADD® INFUSION PUMP WAS ALARMING. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Information

  MAUDE report 7430549 ↗