CADD 21-7375-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10610586027444), received between Feb 24, 2019 and Apr 8, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE IV LINE TUBING GOT DISCONNECTED AT THE FILTER CONNECTION. THE PRODUCT PROBLEM OCCURRED DURING AN INFUSION (IV INFUSION OF AMPICILLIN 2000 MG Q4H X 42 DAYS PICC 1 LUMEN). THE MEDICATION WAS BEING DELIVERED VIA A MULTI-DOSE BAG INTRAVENOUSLY: OVER 1 HOUR, EVERY FOUR HOURS WITH A TKVO RATE OF 2 ML/HOUR CONTINUOUSLY. THE MEDICATION WAS BEING DELIVERED UNDER LOW PRESSURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9942002 ↗
• MalfunctionApr 8, 2020Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE IV LINE TUBING GOT DISCONNECTED AT THE FILTER CONNECTION. THE PRODUCT PROBLEM OCCURRED DURING AN INFUSION (IV INFUSION OF AMPICILLIN 2000 MG Q4H X 42 DAYS PICC 1 LUMEN). THE MEDICATION WAS BEING DELIVERED VIA A MULTI-DOSE BAG INTRAVENOUSLY: OVER 1 HOUR, EVERY FOUR HOURS WITH A TKVO RATE OF 2 ML/HOUR CONTINUOUSLY. THE MEDICATION WAS BEING DELIVERED UNDER LOW PRESSURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9942000 ↗
• MalfunctionApr 3, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION WAS RECEIVED THAT WITH IN USE WITH A PATIENT, A SMITHS MEDICAL CADD ADMINISTRATION SET HAD AIR BUBBLES FORM. NO PATIENT INJURY RESULTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9925436 ↗
• MalfunctionApr 3, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION WAS RECEIVED THAT WITH IN USE WITH A PATIENT, A SMITHS MEDICAL CADD ADMINISTRATION SET HAD AIR BUBBLES FORM. NO PATIENT INJURY RESULTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9925435 ↗
• MalfunctionDec 11, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT AT THE END OF THERAPY WITH A SMITHS MEDICAL CADD ADMINISTRATION SET, IT WAS NOTED THAT THE PUMP SEEMED TO INFUSE SLOWER THAN THE INDICATED VOLUME REMAINING IN CASSETTE. THE REPORTER INDICATED THAT 17% VOLUME REMAINED AFTER INFUSION WAS SUPPOSED TO BE COMPLETE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9451273 ↗
• MalfunctionDec 11, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT AT THE END OF THERAPY WITH A SMITHS MEDICAL CADD ADMINISTRATION SET, IT WAS NOTED THAT THE PUMP SEEMED TO INFUSE SLOWER THAN THE INDICATED VOLUME REMAINING IN CASSETTE. THE REPORTER INDICATED THAT 17% VOLUME REMAINED AFTER INFUSION WAS SUPPOSED TO BE COMPLETE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9451256 ↗
• MalfunctionDec 11, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT AT THE END OF THERAPY WITH A SMITHS MEDICAL CADD ADMINISTRATION SET, IT WAS NOTED THAT THE PUMP SEEMED TO INFUSE SLOWER THAN THE INDICATED VOLUME REMAINING IN CASSETTE. THE REPORTER INDICATED THAT 17% VOLUME REMAINED AFTER INFUSION WAS SUPPOSED TO BE COMPLETE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9451244 ↗
• MalfunctionFeb 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, FLUID LEAKED WAS NOTED. IT WAS REPORTED THAT THE ADMINISTRATION SETS WAS USED FOR HYDRATION WITH TUBING CONNECTED TO AN EXTENSION SETS. ACCORDING TO THE REPORTS WHEN THE EXTENSION SETS WAS CONNECTED, FLUID LEAKED OUT OF THE NEEDLESS ACCESS CONNECTOR AND AROUND THE LUER CONNECTOR OF THE EXTENSION SET. HOWEVER, WHEN THE EXTENSION SET WAS REMOVED, THE FLUID LEAKING STOPPED. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377678 ↗
• MalfunctionFeb 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, FLUID LEAKED WAS NOTED. IT WAS REPORTED THAT THE ADMINISTRATION SETS WAS USED FOR HYDRATION WITH TUBING CONNECTED TO AN EXTENSION SETS. ACCORDING TO THE REPORTS WHEN THE EXTENSION SETS WAS CONNECTED, FLUID LEAKED OUT OF THE NEEDLESS ACCESS CONNECTOR AND AROUND THE LUER CONNECTOR OF THE EXTENSION SET. HOWEVER, WHEN THE EXTENSION SET WAS REMOVED, THE FLUID LEAKING STOPPED. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377677 ↗
• MalfunctionFeb 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, FLUID LEAKED WAS NOTED. IT WAS REPORTED THAT THE ADMINISTRATION SETS WAS USED FOR HYDRATION WITH TUBING CONNECTED TO AN EXTENSION SETS. ACCORDING TO THE REPORTS WHEN THE EXTENSION SETS WAS CONNECTED, FLUID LEAKED OUT OF THE NEEDLESS ACCESS CONNECTOR AND AROUND THE LUER CONNECTOR OF THE EXTENSION SET. HOWEVER, WHEN THE EXTENSION SET WAS REMOVED, THE FLUID LEAKING STOPPED. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377671 ↗
• MalfunctionFeb 24, 2019Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT THE CADD EXTENSION WAS LEAKING AT THE HOSE CONNECTOR. UNFORTUNATELY, THE PATIENT DID NOT NOTICE THIS UNTIL AFTER ABOUT 3 HOURS WHEN HE RAISED HIS BACKPACK WHILE GOING TO BED AND THE PE SOLUTION HAD SWUM TOWARDS HIM. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Patient Involvement

  MAUDE report 8364935 ↗

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