CADD 21-7115-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10610586034503), received between Nov 29, 2020 and Jan 2, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS FOUND AT THE PROXIMAL Y SITE OF THE TUBING. PER REPORTER, THE CAP WAS NEVER HANDLED AND ONLY PART OF THE MEDICATION HAD BEEN ADMINISTERED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951424 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE STARTED TO LEAK. THE PATIENT DID NOT RECEIVE THEIR IV TREATMENT FOR 2 HOURS IN THE NIGHT, AND THEY EXPERIENCED SEIZURES THAT STOPPED WITH THE CHANGE OF TUBING. PER THE REPORTER THERE WAS NO SERIOUS CONSEQUENCES THAT REQUIRED AN INTERVENTION BY A DOCTOR.

  Patient problems: Convulsion/Seizure

  MAUDE report 21903309 ↗
• MalfunctionMar 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE STARTED TO LEAK. THE PATIENT DID NOT RECEIVE THEIR IV TREATMENT FOR 2 HOURS IN THE NIGHT, AND THEY EXPERIENCED SEIZURES THAT STOPPED WITH THE CHANGE OF TUBING. PER THE REPORTER THERE WAS NO SERIOUS CONSEQUENCES THAT REQUIRED AN INTERVENTION BY A DOCTOR.

  Patient problems: Convulsion/Seizure

  MAUDE report 21509821 ↗
• MalfunctionAug 7, 2024Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE TUBING DETACHED AT THE PATIENT'S HOME WITHOUT THE FAMILY HANDLING IT. PER REPORTER, THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THE IDE TESTED 2 OTHER TUBING IN STOCK IN ITS SERVICE- BY FORCING A LITTLE, THE VALVE BROKE ON ONE OF THE OPEN TUBING. ON THE 2ND TUBING, THE VALVE CANNOT BE MISADAPTED. PER REPORTER, THE PROBLEM WAS DISCOVERED DURING USE WITH THE PATIENT. THE ISSUE OF THE DEVICE DID NOT AGGRAVATE THE PATIENT'S CONDITION, BUT THE NURSE HAD TO CHANGE THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931923 ↗
• MalfunctionJul 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PCA TUBING CADD CHECK VALUE EXTENSION SET HAD LEAK AT THE Y-SITE. PER REPORTER, THIS ISSUE WAS EXPERIENCED IN MULTIPLE SETS FROM THIS LOT NUMBER. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOW PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656303 ↗
• MalfunctionMay 15, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE PRODUCT WAS BROKEN AT THE Y SITE AND LEAKED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19323032 ↗
• MalfunctionMay 8, 2024Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO PURGE THE PCA PREPARATION LINE, AND IT APPEARS TO BE CLOGGED, LEADING TO TUBING CHANGE. THE PROBLEM OCCURRED BEFORE THE DEVICE WAS USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272691 ↗
• MalfunctionOct 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISPOSABLE DETACHED. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016319 ↗
• MalfunctionAug 22, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE OF THE SET, THE BLUE CAP THAT CLOSES THE Y-TUBE AFTER THE NON-RETURN VALVE WAS ALLOWING AIR INTO THE TUBE. IT WAS ALSO REPORTED THAT THE ADJACENT MECHANICAL CLAMP HAD NOT BEEN CLOSED THE PREVIOUS DAY AND THAT AIR HAD ENTERED THE MANIFOLD. IT WAS NOT SPECIFIED HOW MUCH AIR HAD ENTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599459 ↗
• MalfunctionAug 22, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE OF THE SET, THE BLUE CAP THAT CLOSES THE Y-TUBE AFTER THE NON-RETURN VALVE WAS ALLOWING AIR INTO THE TUBE. IT WAS ALSO REPORTED THAT THE ADJACENT MECHANICAL CLAMP HAD NOT BEEN CLOSED THE PREVIOUS DAY AND THAT AIR HAD ENTERED THE MANIFOLD. IT WAS NOT SPECIFIED HOW MUCH AIR HAD ENTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599456 ↗
• MalfunctionMar 2, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT, WHEN USING CASSETTES WITH PUMP, AN UNDER DELIVERY ISSUE WAS NOTED. DURING A VISIT OF THE SALES REPRESENTATIVE, IT WAS NOTED THAT THE PUMP HAD NO ISSUE WHEN TESTED WITH OTHER PUMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469502 ↗
• MalfunctionAug 17, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE HAD A LEAK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15239917 ↗
• MalfunctionAug 16, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE HAD A LEAK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235416 ↗
• MalfunctionAug 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "NURSES CAME TO ME AFTER 4 DIFFERENT PATIENTS HAD PCA TUBING THAT WAS LEAKING. AFTER TROUBLE SHOOTING, IT APPEARED THAT ALL THE TUBING SEEMED TO BE LEAKING IN THE SAME SPOT, AT THE Y CONNECTOR." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154388 ↗
• MalfunctionAug 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "NURSES CAME TO ME AFTER 4 DIFFERENT PATIENTS HAD PCA TUBING THAT WAS LEAKING. AFTER TROUBLE SHOOTING, IT APPEARED THAT ALL THE TUBING SEEMED TO BE LEAKING IN THE SAME SPOT, AT THE Y CONNECTOR." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL AND ATTACHED ON 25-MAR-22: CUSTOMER CONFIRMED HE'S REPORTING 2 AFFECTED ITEMS. UPS LABEL REQUESTED. PATIENT INFORMATION IS NOT KNOWN. THE LEAKING WAS IDENTIFIED EARLY AFTER INITIATION SO NO ADVERSE OUTCOME. SLIGHT DELAY WHILE CHANGING TUBING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154386 ↗
• MalfunctionJul 20, 2022Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  IT WAS REPORTED ON (B)(6) 2022, THAT THERE WAS AN INCIDENT WHERE THE PCA TUBING AND IV TUBING HAD A DOWNSTREAM OCCLUSION ON THE IV PUMP THAT LEAD TO ISSUES WITH THE PCA AND IV FLUIDS BEING INFUSED PROPERLY. A BACKFLOW OF BLOOD BEGAN TO BUILD AND WAS VISIBLE IN THE TUBING, AND IT BEGAN TO LEAK AT THE Y SITE ON THE PCA TUBING. THE RN WHO ENCOUNTERED THE ISSUE COMPLETED AN ONPOINT EVENT REPORT. THE TUBING WAS SAVED AND IS CURRENTLY STORED IN CASE ITS NEEDED TO BE SENT BACK TO THE VENDOR. CADD EXTENSION TUBING (WITHOUT THE BLUE LINE); LOT NUMBER NOT AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066186 ↗
• MalfunctionJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING AN INFUSION OF MORPHINE A LEAK WAS FOUND AT THE Y-SITE OF THE TUBING WAS OBSERVED ON SEVERAL OCCASIONS. IT WAS REPORTED THAT SUBSEQUENTLY LOT WAS CHANGED AND THERE WERE NO FURTHER OCCURRENCES. PER REPORTER, THE PATIENT EXPERIENCED AN INCREASE IN PAIN AND NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14563695 ↗
• MalfunctionMay 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE HAD A LEAKAGE AT THE "Y" OF THE TUBING ON SEVERAL OCCASIONS. THE LOT NUMBER HAS BEEN CHANGED AND THE INCIDENT DISAPPEARED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14528625 ↗
• MalfunctionMay 9, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE Y SITE OF THE EXTENSION SET IS NOT ASSEMBLED CORRECTLY (SEE PICTURE ATTACHED IN CUSTOMER NOTIFICATION). DUE TO THAT CONDITION, THE DEVICE CAN'T BE USED. CUSTOMER NOTICED THE ISSUE ON 18 UNITS. 5 WERE WITHDRAWN BY USERS, 13 HAVE BEEN KEPT FOR INVESTIGATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338284 ↗
• MalfunctionFeb 21, 2022Leak/Splash; Insufficient Flow or Under Infusion; Leak/Splash; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING A PUMP USING CADD EXTENSION SET WAS DISCOVERED TO BE LEAKING, AFTER THE NURSE THOUGHT IS WAS THE IV TUBING A CHUCK WAS PLACED UNDER THE IV PUMP AND WAS FOUND TO BE SATURATED IN THE MORNING. THE NURSE CHANGED OUT THE EXTENSION SET TWICE, AS THE FIRST SET LEAKED AGAIN AND THE LEAK WAS VISIBLY LEAKING FROM THE CONNECTION SITE. .

  Patient problems: Insufficient Information

  MAUDE report 13569770 ↗
• MalfunctionNov 1, 2021Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD EXTENSION SET, LEAKING WAS NOTED AT THE ONE-WAY VALVE. SUBSEQUENTLY, THE NURSE HAD TO CHANGE THE TUBING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729663 ↗
• MalfunctionOct 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A CADD EXTENSION SET. IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE END OF THE TUBING WHERE IT ATTACHES INTO THE IV TUBING. THE END OF THE TUBING WAS NOT STRAIGHT, IT SEEMED SLIGHTLY CROOKED/CURVED. IT IS UNKNOWN IF THERE WAS PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THESE OCCURRENCES. NO FURTHER DETAILS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12628013 ↗
• MalfunctionOct 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A CADD EXTENSION SET. IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE END OF THE TUBING WHERE IT ATTACHES INTO THE IV TUBING. THE END OF THE TUBING WAS NOT STRAIGHT, IT SEEMED SLIGHTLY CROOKED/CURVED. IT IS UNKNOWN IF THERE WAS PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THESE OCCURRENCES. NO FURTHER DETAILS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12627996 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE LEAKED AT THE Y SITE AREA. NO ADVERSE EFFECTS REPORTED TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11406065 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE LEAKED AT THE Y SITE AREA. NO ADVERSE EFFECTS REPORTED TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11406025 ↗