CADD 21-6300-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10610586019357), received between Oct 25, 2018 and Sep 2, 2026 — classified as 2 deaths, 88 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (26 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567526 ↗
• MalfunctionJul 14, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817799 ↗
• MalfunctionJun 29, 2026Failure to Sense

  IT WAS REPORTED THAT THE PUMP DOES NOT FUNCTIONAL. UPON FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THE DOWNSTREAM OCCLUSION (DSO) SENSOR WAS NOT FUNCTIONING PROPERLY. THIS MALFUNCTION MAKES THE EVENT REPORTABLE. THERE ARE NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659789 ↗
• MalfunctionJun 23, 2026Mechanical Jam

  IT WAS STATED THAT THE PUMP DOES NOT WORK DURING USE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS CONFIRMED DURING FUNCTIONAL TEST OF A RETURNED PUMP THAT MOTOR CAN¿T MOVE LEC 1871 ERROR DOES APPEAR. IF THE EVENT RECURS DURING INFUSION, IT WILL INTERRUPT THERAPY AND POTENTIALLY IMPACT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600050 ↗
• MalfunctionMay 12, 2026Device Sensing Problem

  IT WAS REPORTED THAT DURING INFUSION IT WAS DETECTED AIR AND OCCLUSION PROBLEM. PATIENT ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149001 ↗
• MalfunctionMay 11, 2026Failure to Infuse

  IT WAS REPORTED THAT DURING INFUSION IT WAS DETECTED AIR AND OCCLUSION PROBLEM. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142587 ↗
• MalfunctionApr 20, 2026Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP NO LONGER RECOGNIZES THE CASSETTE EVEN THOUGH THE PUMP HAD BEEN IN USE FOR A LONG TIME. WHEN THE PUMP WAS REMOVED FROM THE PATIENT AND RETESTED, IT WORKED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930462 ↗
• MalfunctionMar 2, 2026Failure to Infuse

  IT WAS REPORTED THAT THE CASSETTE IS NOT DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480908 ↗
• MalfunctionMar 2, 2026Degraded; Failure to Infuse

  IT WAS STATED THAT THE CASSETTE IS NOT DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480792 ↗
• MalfunctionMar 2, 2026Failure to Infuse

  IT WAS REPORTED THAT THE CASSETTE IS NOT DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480431 ↗
• MalfunctionFeb 20, 2026Device Alarm System

  IT WAS REPORTED THAT THE PUMP HAD ¿AIR DETECTOR MESSAGE¿ DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401566 ↗
• MalfunctionJan 15, 2026Failure to Deliver

  IT WAS REPORTED THAT THE PUMP INDICATED 3 ATTEMPTS / 1 BOLUS ADMINISTERED. NO ADMINISTRATION SCHEDULE APPEARED. THE ELEMENTS COLLECTED POINT TO A MALFUNCTION OF THE BOLUS PEAR BUTTON CONTACTOR: THE PEAR WAS WELL RECOGNIZED BY THE PUMP. ON THE OTHER HAND, SHE NO LONGER TRANSMITTED THE BOLUS ADMINISTRATION ORDER. THE PATIENT WAS UNABLE TO RECEIVE A BOLUS OF MIDAZOLAM AS PART OF A CARE OF A RESPIRATORY DECOMPENSATION ON CANCER ORL. TEST WITH THE CONFIGURATION USED IN THE PATIENT. THE BACKGROUND DOSE WAS WORKING NORMALLY. THE BOLUS COULD NOT BE DELIVERED, DESPITE THE PRESSURES ON THE PEAR. TEST AFTER REPLACEMENT OF THE BOLUS BULB. AN ALARM WAS TRIGGERED AS SOON AS THE OLD BULB WAS REMOVED, SHOWING THAT THE PUMP CORRECTLY DETECTED THE PRESENCE/ABSENCE OF THE ACCESSORY. THE BOLUS THEN ADMINISTERED NORMALLY. THE BOLUS COUNTER UPDATED AS EXPECTED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079765 ↗
• MalfunctionDec 29, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAVING ISSUE WITH BOLUS. PATIENT WAS UNABLE TO RECEIVE A BOLUS OF MIDAZOLAM AS PART OF A CARE OF A RESPIRATORY DECOMPENSATION ON CANCER ORL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914379 ↗
• MalfunctionJul 25, 2025Degraded; Degraded

  THE DEVICE WAS RETURNED DUE TO GETTING LEC 1310 ERROR MESSAGE AND MAINTENANCE. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE'S DOWNSTREAM OCCLUSION (DSO) SENSOR PAD WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609154 ↗
• MalfunctionJun 13, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE CADD OXYCODONE WAS IN CONSTANT PURGE. PER REPORTER, THE PUMP WAS CLAMPED IMMEDIATELY. THE PATIENT WAS ASLEEP AND NOT RESPONSIVE TO STIMULATION. NALOXONE WAS ADMINISTERED TO THE PATIENT WITH OXYGEN AND THE PATIENT WOKE UP AFTER INTERVENTION. REVIEW OF THE DEVICE PROGRAMMING SHOWED NO ABNORMALITY. THE PATIENT RECEIVED 39.2 ML IN A VERY SHORT PERIOD OF TIME. THE OXYCODONE CONCENTRATION WAS 1MG/1ML/HOUR WITH A CONTINUOUS FLOW RATE OF 20 HOURS TO 8 HOURS AT 0.2 ML/HOUR AND BOLUS OF 0.2ML/20 MINUTES. PER REPORTER, THE PATIENT WAS CHECKED BY THE NURSE PRIOR TO THE EVENT, AND THE PATIENT WAS AWAKE WITH NORMAL CONSCIOUSNESS AND NORMAL PARAMETERS. PER REPORTER, THE PATIENT WAS RECEIVING PAIN RELIEF PRIOR TO THIS EVENT. WHEN THE HISTORY OF DOSES WAS RESET TO ZERO IN ORDER TO SEE THE USE MADE BY THE PATIENT, THE NURSE REVIEWED THE HISTORY SHOWED 2 BOLUS ATTEMPTS BUT THAT THE PATIENT RECEIVED ZERO. REPORTER STATED THAT IN VIEW OF THE PATIENT¿S AREACTIVITY (RUDKIN 5), A MEASUREMENT OF PARAMETERS AND A CAPILLARY BLOOD SUGAR TEST IS DONE TO THE PATIENT, AND THE NURSE WAS CHALLENGED BY THE PURGE NOISE OF CADD WHILE IT WAS IN CONSTANT PURGE.

  Patient problems: Loss of consciousness

  MAUDE report 22205785 ↗
• MalfunctionMar 25, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP EXHIBITED ERROR CODE 1871. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21693158 ↗
• MalfunctionMar 19, 2025Failure to Infuse; Material Split, Cut or Torn; Failure to Infuse; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PUMP'S WAS BOLUS CONNECTOR OUT OF SERVICE. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A SPLIT DOWNSTREAM OCCLUSION SENSOR BUTTON. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645377 ↗
• MalfunctionMar 19, 2025Degraded; Failure to Sense; Degraded; Failure to Sense

  IT WAS REPORTED THAT THE PUMP DID NOT CHARGE, AND THE CONNECTOR WAS MOVING. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A DAMAGED DOWNSTREAM OCCLUSION SENSOR. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645363 ↗
• MalfunctionMar 7, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE DEVICE NEEDED REPAIR. THERE WAS UNKNOWN PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED FOR EVALUATION, AND THE CUSTOMER ALLEGED THE PUMP WOULD NOT STOP BEEPING. ANALYSIS OF THE RETURNED DEVICE FOUND THE DOWNSTREAM OCCLUSION SENSOR WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21552742 ↗
• MalfunctionFeb 18, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP DOES NOT DETECT THE CASSETTE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392437 ↗
• MalfunctionJan 20, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE WAS RETURNED FOR AN UNKNOWN REASON. THERE WAS UNKNOWN PATIENT INVOLVEMENT. THE DEVICE EVALUATION FOUND A DAMAGED DOWNSTREAM OCCLUSION SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191819 ↗
• MalfunctionJan 17, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE WAS SENT IN FOR PREVENTATIVE MAINTENANCE, THE DEVICE WAS NO LONGER FUNCTIONING. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE EVALUATION STATED THE DOWNSTREAM OCCLUSION SENSOR WAS FAULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183571 ↗
• MalfunctionJan 16, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE PUMP WAS BROKEN. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THE DOWNSTREAM OCCLUSION SENSOR WAS FAULTY. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173816 ↗
• MalfunctionJan 15, 2025Device Sensing Problem; Device Sensing Problem

  THE PUMP WAS SENT IN FOR REPAIR. THERE WAS UNKNOWN PATIENT INVOLVEMENT. DEVICE EVALUATION REVEALED A DEFECTIVE DOWNSTREAM OCCLUSION SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162366 ↗
• MalfunctionDec 12, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE AIR PROBLEM WAS DETECTED. THE PROBLEM WAS DETECTED WHEN THE TUBING WAS PLACED BEFORE USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918220 ↗