CADD 21-7355-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10610586027376), received between Jan 19, 2018 and Sep 17, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K031361); they may or may not involve this specific model.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT WHILE THE CUSTOMER WAS INFUSING TOTAL PARENTERAL NUTRITION (TPN) WITHOUT LIPIDS USING THE 0.2-MICRON FILTER, DESPITE RIGOROUS PRIMING, REMOVAL OF BUBBLES, AND FOLLOWING STRICT DIRECTIONS ON THE PRODUCT INSERT, THERE WERE MULTIPLE BUBBLES ON THE FLUID PATH WHICH FORM RIGHT BEFORE THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE RISKS OF AIR EMBOLUS FOR THE PATIENT WAS A VERY BIG CONCERN. THE OVERNIGHT TPN WAS INFUSED AT APPROXIMATELY 230 ML/HOUR FOR 12 HOURS. THE EVENT OCCURRED DURING INFUSION. A SAMPLE PHOTO WAS PROVIDED. THE PATIENT RECEIVES HOME TPN. THE REPORTER NOTED THAT THE PRODUCT HAS BEEN USED FOR NIGHTLY HOME TPN VIA PICC AND THE CUSTOMER WAS TOLD BY AMERITA NEXTRON TO CONTINUE USING IT. THE PATIENT IS THE CUSTOMER'S CHILD. THE CUSTOMER WAS VERY CONCERNED ABOUT THE AIR EMBOLI. A SAMPLE PHOTO IS PROVIDED REGARDING THE PRODUCT AND BUBBLES THAT FORM ON THE FLUID PATH DESPITE STRICT ADHERENCE TO PRIMING. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242168 ↗
• MalfunctionMay 15, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE MALE LUER CONNECTOR COMPLETELY SLIPPED OFF THE IV TUBING WITH NO MANIPULATION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323140 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LINE WAS LEAKING; SPLIT TUBING UNDER PLASTIC MOUNT IN THE UNKNOWN SET. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17904710 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LINE WAS LEAKING; SPLIT TUBING UNDER PLASTIC MOUNT IN THE UNKNOWN SET. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17904703 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LINE WAS LEAKING; SPLIT TUBING UNDER PLASTIC MOUNT IN THE UNKNOWN SET. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17904702 ↗
• MalfunctionDec 7, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT A PUMP WAS SCHEDULED TO BE DISCONNECTED FROM THE CADD ADMINISTRATION SET THAT WAS INFUSING DOXORUBICI, DACARBAZINE, INFUSION FOR 24 HOURS OVER THREE DAYS, HOWEVER IT WAS OBSERVED THE BAG STILL HAD AN ESTIMATED 35 TO 40 ML OF THE DRUG REMAINING. IT WAS REPORTED UPON FURTHER INSPECTION OF THE PUMP AND VOLUME READINGS THE PUMP INDICATED 720 ML HAD BEEN INFUSED AT 240 ML OVER THREE DAYS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954037 ↗
• MalfunctionMar 4, 2021Burst Container or Vessel; Leak/Splash; Material Rupture; Burst Container or Vessel; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A PATIENT NOTICED THE TUBING FROM A SMITHS MEDICAL ADMIN SET WAS LEAKING AND THEN IT LITERALLY POPPED APART. THE TUBING WAS LEAKING AND THEN IT LITERALLY POPPED APART. IT'S HAPPENED WITH TWO SEPARATE SETS OF TUBING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11408702 ↗
• MalfunctionMar 4, 2021Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT A PATIENT NOTICED THE TUBING FROM A SMITHS MEDICAL ADMIN SET WAS LEAKING AND THEN IT LITERALLY POPPED APART. THE TUBING WAS LEAKING AND THEN IT LITERALLY POPPED APART. IT'S HAPPENED WITH TWO SEPARATE SETS OF TUBING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11408700 ↗
• MalfunctionJul 29, 2020Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED A PRODUCT DISPOSABLE RELATED TO CADD PUMP CAUSED UNDER DELIVERY. THE DISPOSABLE CAUSED MALFUNCTION, WHICH INTERRUPTED THE TPN THERAPY AND CAUSED UNDER DELIVERY OF THE TPN. TPN IS GIVEN FOR PARENTERAL NUTRITION FOR THE IMMUNE COMPROMISED PATIENT. CUSTOMER STATES THREE TIMES THE FILTER FELL OFF/CAME APART. AIR WAS IN LINE. WASTED TPN INFUSION DRUG. OCCURRED IMMEDIATELY ON USE AND DURING REMOVAL OR AT THE END OF THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339214 ↗
• MalfunctionJul 29, 2020Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED A PRODUCT DISPOSABLE RELATED TO CADD PUMP CAUSED UNDER DELIVERY. THE DISPOSABLE CAUSED MALFUNCTION, WHICH INTERRUPTED THE TPN THERAPY AND CAUSED UNDER DELIVERY OF THE TPN. TPN IS GIVEN FOR PARENTERAL NUTRITION FOR THE IMMUNE COMPROMISED PATIENT. CUSTOMER STATES THREE TIMES THE FILTER FELL OFF/CAME APART. AIR WAS IN LINE. WASTED TPN INFUSION DRUG. OCCURRED IMMEDIATELY ON USE AND DURING REMOVAL OR AT THE END OF THERAPY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339089 ↗
• MalfunctionJul 29, 2020Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED A PRODUCT DISPOSABLE RELATED TO CADD PUMP CAUSED UNDER DELIVERY. THE DISPOSABLE CAUSED MALFUNCTION, WHICH INTERRUPTED THE TPN THERAPY AND CAUSED UNDER DELIVERY OF THE TPN. TPN IS GIVEN FOR PARENTERAL NUTRITION FOR THE IMMUNE COMPROMISED PATIENT. CUSTOMER STATES THREE TIMES THE FILTER FELL OFF/CAME APART. AIR WAS IN LINE. WASTED TPN INFUSION DRUG. OCCURRED IMMEDIATELY ON USE AND DURING REMOVAL OR AT THE END OF THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338954 ↗
• MalfunctionApr 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD ADMINISTRATION SETS EXPERIENCED LEAKING AROUND THE FILTER AREA. IT WAS REPORTED THAT IT WAS UNSURE HOW MUCH OF THE DOSES THE PATIENT RECEIVED WHEN THE LEAKING WAS NOTED. ACCORDING TO THE REPORT, THE PATIENT THROWED AWAY THE MEDICATION BAG AND STARTED OVER WITH A FRESH TUBING. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8525216 ↗
• InjuryJan 19, 2018Failure to Deliver; Infusion or Flow Problem; Failure to Deliver; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD® HIGH-VOLUME ADMINISTRATION SET WAS DIFFICULT TO PRIME FOR A SCHEDULED INFUSION OF 1500 CC OF NORMAL SALINE (NS). THE PATIENT FOUND THE NEXT DAY THAT NONE OF THE NORMAL SALINE WAS ADMINISTERED OVERNIGHT. THE TUBING WAS DISCONNECTED FROM THE PORT AND THE PUMP WAS NOTED TO BE PUMPING AS NORMAL BUT THAT THE FLUID WAS NOT ADVANCING THROUGH THE LINE. TOTAL PARENTERAL NUTRITION (TPN) WAS BEING ADMINISTERED AT SAME TIME WITH NO PROBLEMS REPORTED. THE PATIENT REPORTED FEELING "DEHYDRATED" WITH DIARRHEA THE PRIOR DAY. NO ADVERSE EFFECTS WERE REPORTED BUT A TWO LITER BOLUS OF NORMAL SALINE WAS ORDERED AND INFUSED.

  Patient problems: Dehydration; Diarrhea

  MAUDE report 7205600 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031361. One submission often covers many models, so check the product and lot details in each record.

• Z-0962-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
• Z-0148-2022 · Jul 14, 2020 · Terminated
  CADD Administration Sets, Model #21-7346-24
• Z-2589-2017 · May 15, 2017 · Terminated
  CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid