CADD 21-7047-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 10610586020315), received between Jul 6, 2017 and May 14, 2026 — classified as 5 injuries, 253 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (104 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 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP HAD BEEN ALARMING ERROR 45636. THE PATIENT HAD STATED THAT THE PUMP HAD BEEN LEAKING AND THAT A WET SPOT HAD BEEN NOTICED ON HER PANTS, WITH THE CARRYING CASE ALSO WET. THE PATIENT HAD BEEN INSTRUCTED TO OPEN AND THEN CLOSE THE BATTERY DOOR. A LOSS OF POWER ALARM HAD BEEN ACKNOWLEDGED. THE PUMP HAD BEEN POWERED DOWN, AND THE CLAMP ON THE TUBING CLOSEST TO THE PICC LINE HAD BEEN CLOSED. THE PUMP HAD BEEN PLACED IN A BIOHAZARD BAG. THE PATIENT HAD BEEN INSTRUCTED TO CALL THE DOCTOR IMMEDIATELY AND HAD BEEN INFORMED THAT THE INFUSION COULD NOT BE STOPPED FOR MORE THAN FOUR HOURS. THE MEDICATION HAD BEEN BLINCYTO. THERE WERE NO INJURY AND THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176708 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS WHITE RESIDUE PRESENT IN THE MEDICATION BAG AND ALL OVER THE PUMP. THE PATIENT WAS UNABLE TO CONFIRM THE PUMP SETTINGS BECAUSE THE SCREEN WAS COVERED WITH WHITE RESIDUE. SPILL KIT INSTRUCTIONS WERE PROVIDED, AND THE PATIENT WAS INSTRUCTED TO POWER THE PUMP OFF AND CONTACT THE CLINIC IMMEDIATELY. THE PATIENT AGREED TO CALL THE CLINIC AT THAT TIME. THE EVENT OCCURRED DURING WHILE IN USE WITH PATIENT WITH NO HARM. IT TOOK PLACE AT THE PATIENT¿S HOME, AND THE DEVICE WAS OPERATED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164874 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED AND APPEARED TO HAPPEN AT THE CASSETTE TO EXTENSION TUBING CONNECTION. THE EVENT OCCURRED WHILE IN USE WITH PATIENT, AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008442 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S PUMP BECAME LOOSE WHERE PUMP AND EXTENSION SET ATTACHES. PATIENT HAD TO CLEAN UP THE SPILL FROM DISCONNECTION WITH CADD AND EXTENSION SET. AT INITIAL HOOKING UP NO LEAKAGE OR ISSUES WERE NOTICED BY PHARMACY OR NURSING. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839066 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHEMOTHERAPY LEAK. THE PATIENT ARRIVED WITH 5FU CADD PUMP INFUSION COMPLETE. WHEN THEY WENT TO UNHOOK HER CADD PUMP, THEY NOTICED A WHITE POWDER RESIDUE AROUND WHERE THE TUBING WAS CONNECTING TO THE BLUE NEEDLELESS CONNECTOR. THE CONNECTION BETWEEN THE TUBING AND THE CONNECTOR WAS TIGHT, THE CONNECTION BETWEEN THE EQUASHEILD SYSTEM WAS ALSO TIGHT. THE WHITE POWDER RESIDUE WAS ALSO ON THE PATIENTS' ABDOMEN AND THE INSIDE OF HER SHIRT. THE PATIENT DENIED FEELING ANY WETNESS AROUND THE PUMP OR TUBING AND DENIED NOTICING ANY OF THE WHITE POWDER RESIDUE ON HER NIGHTGOWN OR BEDDING. THE PATIENT WAS DISMISSED HOME IN STABLE CONDITION. TUBING WAS DISCARDED BY THE FACILITY. NO PATIENT HARM AND INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629602 ↗
• MalfunctionMar 13, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE BAG HAD APPEARED EMPTY, WHILE THE PUMP HAD INDICATED THAT 8 ML REMAINED. THERE WAS NO INJURY. 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 24598896 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED WITH THE CADD EXTENSION SET. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533229 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS LEAKING FROM THE CONNECTOR AND THERE WAS WHITE POWER ON THE PUMP AND BAG. THEY WERE INSTRUCTED TO PUT THE PUMP IN A CHEMO SPILL BAG. THE PUMP WAS POWERED OFF, CLAMP TUBING, AND THEY WERE EDUCATED ON CHEMO SPILL PROTOCOL. THE MEDICATION USED WAS 5FU. THE LEAK FOR THIS TIME AND THE PREVIOUS LEAK OCCURRED AT THE SAME PLACE WHERE THE EXTENSION SET AND SWIVEL PIECE WERE CONNECTED. BOTH LEAKS HAVE BEEN SHARED WITH THEM. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521408 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PUMP HAD BEEN RETURNED COMPLETELY SOAKED. THE TUBING HAD BEEN INSPECTED, AND IT HAD APPEARED THAT THE TUBING HAD BECOME DETACHED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513297 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP HAD ALARMED ¿NO DISPOSABLE CLAMP TUBING.¿ THE PUMP HAD BEEN STOPPED, BUT THE DOUBLE-BEEP ALARM HAD PERSISTED. THE LINE HAD BEEN CLAMPED AND THE CASSETTE HAD BEEN REMOVED. THE TUBING HAD BEEN MASSAGED, AND A SMALL BUBBLE HAD BEEN NOTED. THE CASSETTE HAD BEEN RECONNECTED, BUT THE DOUBLE-BEEP ALARM HAD BEGUN AGAIN. THE CASSETTE HAD THEN BEEN REMOVED AND TAPPED ON A HARD SURFACE BEFORE BEING RECONNECTED, BUT THE PUMP HAD BEEN UNABLE TO START AND THE ALARMING HAD CONTINUED. THE PUMP HAD BEEN POWERED OFF, AND THE LINE HAD REMAINED CLAMPED. THE PATIENT HAD BEEN INSTRUCTED TO CONTACT THE CLINIC IMMEDIATELY. THE RESERVOIR VOLUME HAD BEEN 243.8ML, THE INFUSION RATE HAD BEEN 5.4ML PER HOUR, AND 6.2ML HAD BEEN DELIVERED. THE PATIENT HAD NOT BEEN MEDICALLY AFFECTED. 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 CASSETTE AND PUMP COMPLAINTS DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434663 ↗
• MalfunctionFeb 24, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PUMP HAD INDICATED THAT 114 ML HAD BEEN DELIVERED, BUT UPON RETURN, APPROXIMATELY 16 ML OF 5-FU HAD REMAINED IN THE CASSETTE. IT WAS CONSIDERED POSSIBLE THAT THE CASSETTE HAD BEEN OVERFILLED, ALTHOUGH 16 ML WAS MORE THAN EXPECTED. THE 5-FU HAD BEEN LOADED INTO A 250 ML CASSETTE. THE PATIENT HAD REPORTED THAT NO ALARMS HAD BEEN TRIGGERED DURING THE INFUSION. THE CONTINUOUS INFUSION HAD BEEN DELIVERED AT 2.5 ML PER HOUR WITH A TOTAL RESERVOIR VOLUME OF 114 ML, OF WHICH 98 ML HAD BEEN ADMINISTERED, WHILE THE AIR DETECTOR AND UPSTREAM SENSOR HAD REMAINED OFF THROUGHOUT THE 46-HOUR INFUSION, WITH THE PUMP SET AT LOCK LEVEL 2, THE PUMP HAVING BEEN USED TO PRIME THE EXTENSION TUBING, AND THE PATIENT NOT HAVING BEEN MEDICALLY AFFECTED. 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 AND CASSETTE COMPLAINT DOCUMENTED ON (B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434629 ↗
• MalfunctionFeb 19, 2026Failure to Infuse

  IT WAS REPORTED THAT THE TUBING HAD BEEN DISCONNECTED AT THE CONNECTION NEAREST THE PORT. THE DEVICE HAD ALREADY BEEN STOPPED BY THE PATIENT. ASSISTANCE HAD BEEN PROVIDED TO CLAMP THE TUBING NEAR THE PORT AND NEAR THE PUMP. CHEMO SPILL INSTRUCTIONS HAD BEEN PROVIDED. THE PATIENT HAD DENIED THE PRESENCE OF BLOOD IN THE TUBING NEAR THE PORT. HE HAD BEEN INSTRUCTED TO CALL THE AFTER-HOURS NUMBER PER SPECIAL FACILITY INSTRUCTIONS. THERE WAS NO INJURY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390323 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP HAD BEEN ALARMING ERROR 45636. THE PATIENT HAD STATED THAT THE PUMP HAD BEEN LEAKING AND THAT A WET SPOT HAD BEEN NOTICED ON HER PANTS, WITH THE CARRYING CASE ALSO WET. THE PATIENT HAD BEEN INSTRUCTED TO OPEN AND THEN CLOSE THE BATTERY DOOR. A LOSS OF POWER ALARM HAD BEEN ACKNOWLEDGED. THE PUMP HAD BEEN POWERED DOWN, AND THE CLAMP ON THE TUBING CLOSEST TO THE PICC LINE HAD BEEN CLOSED. THE PUMP HAD BEEN PLACED IN A BIOHAZARD BAG. THE PATIENT HAD BEEN INSTRUCTED TO CALL THE DOCTOR IMMEDIATELY AND HAD BEEN INFORMED THAT THE INFUSION COULD NOT BE STOPPED FOR MORE THAN FOUR HOURS. THE MEDICATION HAD BEEN BLINCYTO. THERE WERE NO INJURY AND THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245867 ↗
• MalfunctionFeb 3, 2026Obstruction of Flow; Blocked Connection

  IT WAS REPORTED THAT A DOWNSTREAM OCCLUSION BETWEEN THE PUMP AND THE PATIENT HAD OCCURRED. THE PATIENT¿S PORT HAD BEEN FLUSHED WITHOUT ISSUE, AND THE CLAMP ON THE CHEMO LINE HAD NOT BEEN CLOSED. ATTEMPTS TO RESOLVE THE ISSUE BY CHANGING OUT THE CADD PUMP HAD NOT BEEN SUCCESSFUL. ONCE A NEW CASSETTE HAD BEEN USED, THE PUMP HAD INFUSED WITHOUT ISSUE. THE CONTINUOUS INFUSION RATE HAD BEEN 2.2 ML PER HOUR; WITH A RESERVOIR VOLUME OF 100 ML. NO DRUG HAD BEEN ADMINISTERED PRIOR TO RESOLUTION. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE FACILITY. THE PATIENT HAD BEEN MEDICALLY AFFECTED BY A DELAY IN STARTING THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245693 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP HAD LEAKED. THERE WAS WHITE RESIDUE ALL OVER THE BAG. THERE WAS NO PUMP ALARM NOTED BY THE PATIENT. UPON INVESTIGATION, IT WAS NOTED THAT THE LEAK HAD COME FROM THE CONNECTION WHERE THE PUMP CASSETTE MEETS THE EXTENSION TUBING AND THERE WAS NO INJURY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23965129 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP HAD WHITE STUFF ALL OVER IT ALONG WITH THE CARRYING CASE. THEY INSTRUCTED THE PATIENT TO STOP THE PUMP, POWER IT OFF, AND TO CLAMP THE TUBING. THE CHEMO SPILL INSTRUCTIONS WERE PROVIDED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959461 ↗
• MalfunctionDec 15, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING WAS DISCONNECTED IN THE SAME SPOT THAT THE PREVIOUS LINE DID. THE END OF THE TUBING HAS A WHITE CAP ON IT THAT THEY ATTACHED TO THE PORT TUBING. THE WHITE CAP COMES OFF. THERE WAS NO PATIENT HARM OR NO PATIENT INJURY, AND THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802529 ↗
• MalfunctionNov 25, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD ALARMED NO DISPOSABLE CLAMP TUBING. THE PATIENT HAD NOT BEEN MEDICALLY AFFECTED. 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 23649363 ↗
• MalfunctionNov 17, 2025Disconnection; Failure to Infuse; Disconnection; Failure to Infuse

  IT WAS REPORTED THAT THE TUBING CONTINUES TO POP APART AND THEY CANNOT KEEP IT CONNECTED. IT WAS DISCONNECTING AT THE BLUE CONNECTOR PIECE NEAREST THE PORT. THE PUMP STOPPED. THEY STATED THAT NOTHING LEAKED OUT WHEN IT WAS DISCONNECTED. THEY INSTRUCTED TO CLOSE THE CLAMP NEAREST THE PORT. THE PUMP POWERED OFF. PHOTO WAS PROVIDED. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. ASSOCIATED CASSETTE AND PUMP COMPLAINTS DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570265 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING WAS DISCONNECTED FROM THE CASSETTE TUBING AND THE MEDICATION THAT WAS INFUSED INTO THE CARRIER POUCH SPILL INTO THE PUMP DURING PATIENT USE. NO PATIENT HARM OR NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23515018 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING WAS DISCONNECTED FROM THE CASSETTE TUBING AND THE MEDICATION THAT WAS INFUSED INTO THE CARRIER POUCH SPILL INTO THE PUMP DURING PATIENT USE. NO PATIENT HARM OR NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514120 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP LEAKED AND THEN IT TURNED OFF ON ITS OWN, POSSIBLY DUE TO LIQUID DAMAGE. THE PUMP WAS POSSIBLY CONTAMINATED WITH CHEMO. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458170 ↗
• MalfunctionOct 28, 2025No Audible Alarm; Fluid/Blood Leak; No Audible Alarm; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE CLINIC FOR A PUMP EXCHANGE DUE TO A CRACK IN THE TUBING. CHEMOTHERAPY HAD LEAKED ONTO THE POUCH, AND THE CASSETTE WAS FOUND TO BE EMPTY. THE PATIENT REPORTED THAT THE PUMP HAD NOT ALERTED THEM THAT THE CASSETTE WAS EMPTY. THE FACILITY BELIEVED THAT THE PUMP SHOULD HAVE PROVIDED AN ALERT. THE INFUSION HAD BEEN SET AT A CONTINUOUS RATE OF 1.8 ML/HR, WITH A STARTING RESERVOIR VOLUME OF 200 ML AND A PLANNED INFUSION LENGTH OF 96 HOURS. THE DRUG ADMINISTERED WAS BLINCY TO. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING. INSTEAD, THE TUBING HAD BEEN MANUALLY PRIMED IN THE CHEMOTHERAPY COMPOUNDING HOOD. THERE WAS NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407518 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHEMO LEAKED AT LAST TREATMENT, THEY WERE NOT SURE IF IT CAME FROM THE LINE OR PORT AS THE CHEMO INFILTRATED INTO THE PATIENT'S CHEST. THEY HAD THE TUBING AND PUMP FOR RETURN IF WANTED. THERE WAS NO REPORTED PATIENT HARM. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372274 ↗
• MalfunctionOct 22, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED AND THE TUBING WAS COMPLETELY DISCONNECTED NEAR THE CADD PUMP CONNECTION. THERE WERE PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357481 ↗