CADD 21-7044-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 15019517184204), received between Jul 2, 2024 and May 12, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE AND THE FILTER WAS CRYSTALIZED ON THE OUTSIDE, THE SEAL WOULD HAVE BEEN BROKEN. THIS EVENT OCCURRED WHILE IN USE WITH PATIENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153029 ↗
• MalfunctionMay 5, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP WAS UNDER DELIVERED AND BEEPING ON THE DAY PRIOR TO PUMP DISCONNECTION. WHEN THE PUMP WAS DISCONNECTED, THE CASSETTE WAS EMPTY, YET THE PUMP DISPLAY STILL SHOWED 27 ML REMAINING TO BE INFUSED. THE MEDICATION 5FU (5 FLUOROURACIL) WAS INFUSED AT RATE OF 3.3 ML PER HOUR. OF THE TOTAL, 150 ML HAD BEEN ADMINISTERED, WITH 27 ML INDICATED AS REMAINING. THIS EVENT OCCURRED DURING INFUSION AT THE PATIENT¿S HOME. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085212 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING WAS LEAKING OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663785 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING WAS LEAKING ON THE SIDE WHERE THE SEAM WAS ON THE FILTER ITSELF. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980166 ↗
• MalfunctionDec 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING FROM THE FILTER ON THE SIDE WHILE IN USE WITH A PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898556 ↗
• MalfunctionDec 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET WAS LEAKING FROM THE FILTER ON THE SIDE WHILE IN USE WITH A PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897389 ↗
• MalfunctionNov 20, 2025Crack; Disconnection; Material Split, Cut or Torn; Crack; Disconnection; Material Split, Cut or Torn

  IT WAS REPORTED THAT APPROXIMATELY 3 HOURS AFTER THE PUMP WAS STARTED AND THE TUBING DRIED AND BROKE IN 2 PLACES. THE PUMP HAD BEEN STOPPED. UPON INSPECTION OF THE TUBING, IT APPEARS TO HAVE 2 CLEAN CUTS. THERE WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612166 ↗
• MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING EXHIBITED A LEAKAGE. A NEW PUMP WAS USED, AND THE PATIENT RECEIVED THE APPROPRIATE DOSE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952544 ↗
• MalfunctionAug 12, 2025Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  IT WAS REPORTED THAT THE PATIENT¿S TUBING HAD BECOME SEPARATED. CHEMOTHERAPY SPILL INSTRUCTIONS HAD BEEN PROVIDED, AND SHE HAD BEEN ADVISED TO CALL THE CLINIC FIRST THING IN THE MORNING FOR FURTHER GUIDANCE. THE MEDICATION INVOLVED 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 22787163 ↗
• MalfunctionAug 4, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE EXTENSION LINES WERE FILLING WITH AIR WHILE BEING USED WITH A CASSETTE AND MICRON FILTER. REPORTER STATED THAT THE AIR ISSUE RESULTED IN THE PUMP STOPPING EARLY. REPORTER STATED THAT THE ISSUE WAS DISCOVERED WHEN THE PATIENT WAS ALREADY ON SITE TO HAVE THE CASSETTE CHANGED, AND LARGE SECTIONS ON AIR WERE DISCOVERED IN THE LINES. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702254 ↗
• MalfunctionAug 4, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE EXTENSION LINES WERE FILLING WITH AIR WHILE BEING USED WITH A CASSETTE AND MICRON FILTER. REPORTER STATED THAT THE AIR ISSUE RESULTED IN THE PUMP STOPPING EARLY. REPORTER STATED THAT THE ISSUE WAS DISCOVERED WHEN THE PATIENT WAS ALREADY ON SITE TO HAVE THE CASSETTE CHANGED, AND LARGE SECTIONS ON AIR WERE DISCOVERED IN THE LINES. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702250 ↗
• MalfunctionAug 4, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE EXTENSION LINES WERE FILLING WITH AIR WHILE BEING USED WITH A CASSETTE AND MICRON FILTER. REPORTER STATED THAT THE AIR ISSUE RESULTED IN THE PUMP STOPPING EARLY. REPORTER STATED THAT THE ISSUE WAS DISCOVERED WHEN THE PATIENT WAS ALREADY ON SITE TO HAVE THE CASSETTE CHANGED, AND LARGE SECTIONS ON AIR WERE DISCOVERED IN THE LINES. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702247 ↗
• MalfunctionMar 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT TWO PUMPS ALARMED DOWNSTREAM OCCLUSION WITH AN EXTENSION SET. REPORTER STATED THE EXTENSION SET WAS PUT THE RIGHT WAY, CLAMPS WERE OPEN, STRAIGHT AND NOT BENT. REPORTER STATED THEY TOOK A NEW EXTENSION SET AND PUT IT TO THE CASSETTE AND WITH BOTH PUMPS STILL GOT DOWNSTREAM OCCLUSION ALARMS. AFTER THESE ATTEMPTS, A THIRD PUMP WAS USED, AND ONE EXTENSION SET WAS ABLE TO BE PRIMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594030 ↗
• MalfunctionMar 13, 2025Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow

  IT WAS REPORTED THAT TWO PUMPS ALARMED DOWNSTREAM OCCLUSION WITH AN EXTENSION SET. REPORTER STATED THE EXTENSION SET WAS PUT THE RIGHT WAY, CLAMPS WERE OPEN, STRAIGHT AND NOT BENT. REPORTER STATED THEY TOOK A NEW EXTENSION SET AND PUT IT TO THE CASSETTE AND WITH BOTH PUMPS STILL GOT DOWNSTREAM OCCLUSION ALARMS. AFTER THESE ATTEMPTS, A THIRD PUMP WAS USED, AND ONE EXTENSION SET WAS ABLE TO BE PRIMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593991 ↗
• MalfunctionFeb 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S PARENTS DISCOVERED THAT JUST BEFORE 6 PM, THE UNIT FOR THE INFUSION PUMP WAS LEAKING. THERE WERE TWO SMALL SPOTS ON THE BOY¿S PANTS. THEY PLACED A PAPER UNDER THE TUBE, AND IT LEAKED EVERY TIME THE PUMP DELIVERED FLUID. NO LEAKAGE WAS NOTED WHEN THE PUMP WAS CHECKED AT 3 PM. IT APPEARED TO BE LEAKING AT THE JOINT BETWEEN THE PLASTIC TUBE AND THE SMALL CONNECTOR. THEY REPLACED THE TUBE WITH A NEW ONE AND CONTACTED THE ONCOLOGY SERVICE. FOUR ML OF MEDICATION WAS LOST. NO FURTHER LEAKAGE HAS BEEN OBSERVED AFTER REPLACING THE TUBE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364515 ↗
• MalfunctionNov 19, 2024Failure to Infuse; Obstruction of Flow; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT WHEN MAKING CHANGES ON THE PUMP, THE PUMP ALARMED FOR OCCLUSION. IT WAS TRIED TO PRIME AGAIN; HOWEVER, IT STILL WAS NOT WORKING AND THEN THEY HAD TO USE ANOTHER EXTENSION. THE PATIENT HAD 2 EXTENSIONS THAT DID NOT WORK. THE EVENT DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727349 ↗
• MalfunctionNov 18, 2024Failure to Prime; Failure to Infuse; Obstruction of Flow; Failure to Prime; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT WHEN MAKING CHANGES ON THE PUMP, THE PUMP ALARMED FOR OCCLUSION. IT WAS TRIED TO PRIME AGAIN, HOWEVER IT STILL WAS NOT WORKING AND THEN THEY HAD TO USE ANOTHER EXTENSION. THE PATIENT HAD 2 EXTENSIONS THAT DID NOT WORK. THE EVENT DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20714651 ↗
• MalfunctionJul 2, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT ADMINISTRATION SET WAS DISCOVERED BROKEN NEAR THE CONNECTION POINT WITH THE BROVIAC LINE. A SMALL WET PATCH ON THE BED SUGGESTED THAT IT HAD BEEN BROKEN AND DISCONNECTED FROM THE PATIENT FOR A FEW MINUTES. IT WAS IMPOSSIBLE TO ESTABLISH EXACTLY HOW LONG, BUT IT WAS SOMEWHERE BETWEEN 23.30 AND 00.30. IT MUST HAVE BECOME DISCONNECTED WHEN THE PATIENT TURNED IN BED. MUM WAS ALERTED IMMEDIATELY. SHE REPLACED THE ADMINISTRATION SET AND RECONNECTED THE INFUSION USING ASEPTIC TECHNIQUE. THE PATIENT APPEARED WELL AND STABLE FOLLOWING THIS. ALL VITALS REMAINED ADEQUATE, NO ADVERSE REACTIONS AS A RESULT OF THE INCIDENT NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660919 ↗