CADD 21-7059-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10610586020421), received between Sep 13, 2018 and Nov 11, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UPON OPENING THE CHEMOTHERAPY TRANSPORT BAG, A LARGE AMOUNT OF CHEMOTHERAPY HAD LEAKED FROM THE 5-FLUOROURACI CHEMO BAG ONTO THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522162 ↗
• MalfunctionNov 18, 2024Excess Flow or Over-Infusion; Obstruction of Flow; Excess Flow or Over-Infusion; Obstruction of Flow

  IT WAS REPORTED THAT THE PUMP WAS ALARMING UPSTREAM OCCLUSION. PER REPORTER, THE PUMP DID RETURN TO RUNNING BUT ALARM DID RETURN. REPORTER STATED THE BAG OF MEDICATION WAS EMPTY. PER LABEL: TOTAL VOLUME- 138ML, CONTINUOUS RATE- 3ML/HOUR OVER 46 HOURS. PUMP SETTINGS: RESERVOIR VOLUME- 11.1ML, GIVEN- 126.98, RATE- 3ML/HOUR. STARTING VOLUME: 138 ML. CONTINUOUS INFUSION RATE: 3 ML/HOUR. RESERVOIR VOLUME: 11.1 ML (DISPLAYED ON PUMP). GIVEN: 126.98 ML. AIR DETECTOR WAS OFF. UPSTREAM SENSOR WAS ON. LENGTH OF INFUSION: 46 HOURS. LOCK LEVEL: 2. THE LINE PRIMED MANUALLY. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20715827 ↗
• MalfunctionSep 16, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE DEVICE OVER INFUSED. PER REPORTER, THE STARTING VOLUME WAS 138ML, CONTINUOUS INFUSION RATE: 3ML/HOUR, RESERVOIR VOLUME: 10.1 ML ON THE PUMP SETTINGS AND GIVEN: 138 ML. THE AMOUNT OF MEDICATION REMAINING IN CASSETTE DID NOT MATCH THE RESERVOIR VOLUME DISPLAYED ON THE PUMP. THEY DID NOT ATTEMPT TO WITHDRAW THE REMAINING MEDICATION IN THE RESERVOIR TO CONFIRM BECAUSE THE BAG WAS EMPTY. THE AIR DETECTOR WAS OFF, AND THE UPSTREAM SENSOR WAS ON. THE LENGTH OF INFUSION INTENDED: 46 HOURS. LENGTH OF INFUSION (ACTUAL): 42.5HRS. THEY USED A SYRINGE AS THE LINE PRIMED WHEN THE PUMP WAS NOT USED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231109 ↗
• MalfunctionApr 19, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE FACILITY CALLED REGARDING A PUMP. STATED THAT PATIENT CAME IN WITH PUMP. THE PUMP WAS REPORTING THAT THERE WAS 3.6 ML LEFT BUT THE MEDICATION BAG WAS DRY AND PUMP WAS PULLING IN AIR. PUMP SETTINGS ALSO STATED THAT PATIENT RECEIVED 54 ML BUT TOTAL VOLUME WAS 58 ML. THEY HAD THIS ATTACHED TO A WALKMED BAG. THE TUBING IS NOT AVAILABLE FOR RETURN. THE EVENT TOOK PLACE AT THE PATIENT'S HOME. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144316 ↗
• MalfunctionFeb 15, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING USE, THE DEVICE OVER-INFUSED MEDICATION. THE PATIENT WAS SENT HOME WITH 115ML AT 2.5ML/HOUR AND THE NEXT DAY HE PRESENTED TO DISCONNECT THE PUMP WITH THE PUMP SHOWING 10.1ML REMAINING BUT THE BAG WAS EMPTY. PER THE REPORTER, THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717742 ↗
• MalfunctionMay 25, 2023Failure to Deliver; Inaccurate Delivery; Failure to Deliver; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE HAS HAD SEVERAL UNDER OR COMPLETE NON-INFUSION OF MEDICATION USING THE HCT BAGS AND TUBING'S. NO PATIENT INJURY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005350 ↗
• MalfunctionMay 12, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE UNDER DELIVERED OR A COMPLETE NON-INFUSION OF MEDICATION USING THE HCT BAGS AND DISPOSABLE. PATIENT NOT AFFECTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919004 ↗
• MalfunctionApr 21, 2023Inaccurate Delivery; Device Fell; Inaccurate Delivery; Device Fell

  IT WAS REPORTED THE DISPOSABLE UNDER INFUSED. DEVICE FELL ON THE FLOOR. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790808 ↗
• MalfunctionApr 12, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION INCIDENT (250 ML) INVOLVING A CADD ADMINISTRATION SET. THE PROBLEM OCCURRED DURING PATIENT USE. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724526 ↗
• MalfunctionNov 23, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT A CADD ADMINISTRATION SET UNDER INFUSED. IT WAS REPORTED THE RESIDUAL VOLUME SHOWED 21 ML WAS LEFT IN THE RESERVOIR BAG, HOWEVER THE PUMP WAS READING EMPTY. PER REPORTER STARTING VOLUME WAS: 250 ML, RATE 5.4 AND THE RESIDUAL VOLUME WAS 21 ML. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861659 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION INCIDENT (250 ML) INVOLVING A SMITHS MEDICAL CADD ADMINISTRATION SET. THE PROBLEM OCCURRED DURING PATIENT USE. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046974 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION INCIDENT (250 ML) INVOLVING A SMITHS MEDICAL CADD ADMINISTRATION SET. THE PROBLEM OCCURRED DURING PATIENT USE. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046973 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION INCIDENT (250 ML) INVOLVING A SMITHS MEDICAL CADD ADMINISTRATION SET. THE PROBLEM OCCURRED DURING PATIENT USE. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046953 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION INCIDENT (250 ML) INVOLVING A SMITHS MEDICAL CADD ADMINISTRATION SET. THE PROBLEM OCCURRED DURING PATIENT USE. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046947 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION INCIDENT (250 ML) INVOLVING A SMITHS MEDICAL CADD ADMINISTRATION SET. THE PROBLEM OCCURRED DURING PATIENT USE. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046942 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS AN UNDER-INFUSION INCIDENT (250 ML) INVOLVING A SMITHS MEDICAL CADD ADMINISTRATION SET. THE PRODUCT PROBLEM OCCURRED DURING PATIENT USE. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046890 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, UNDER INFUSION WAS NOTED. IT WAS REPORTED THAT THE PATIENT RETURNED WITH MORE THAN 20 CC REMAINING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040529 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, UNDER INFUSION WAS NOTED. IT WAS REPORTED THAT THE PATIENT RETURNED WITH MORE THAN 20 CC REMAINING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040465 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, UNDER INFUSION WAS NOTED. IT WAS REPORTED THAT THE PATIENT RETURNED WITH MORE THAN 20 CC REMAINING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040439 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, UNDER INFUSION WAS NOTED. IT WAS REPORTED THAT THE PATIENT RETURNED WITH MORE THAN 20 CC REMAINING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040402 ↗
• MalfunctionJun 22, 2021Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, UNDER INFUSION WAS NOTED. IT WAS REPORTED THAT THE PATIENT RETURNED WITH MORE THAN 20 CC REMAINING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040254 ↗
• MalfunctionJun 4, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE PATIENT ARRIVED TO INFUSION CENTER. HE TURNED THE PUMP OFF BECAUSE OF AN ALARM (UNKNOWN AT THIS TIME). THE BAG APPEARED TO BE EMPTY SO HE TURNED OFF THE PUMP AND WENT TO INFUSION CENTER. PUMP WAS TO INFUSE OVER 120 HOURS AND WHEN HE ARRIVED TO CLINIC THERE SHOULD HAVE BEEN 13.5 HOURS REMAINING. ERICA, RN STATED THAT THERE WAS NOT 47.9 ML IN THE BAG AND THE BAG WAS IN FACT EMPTY. MEDICATION: 5FU. SETTINGS AT START OF INFUSION: 500ML TO BE INFUSED AT 4.2 ML/H OVER 120 HOURS. SETTINGS UPON RETURN TO CLINIC: RES VOL: 47.9ML, RATE: 4.2ML/H, GIVEN: 450.45ML. PROGRAMMING VERIFIED. GREATER THAN 6% DISCREPANCY. NO OVERFILL IS ADDED TO BAG. CADD SET 21-7059-24 LOT# 4080929. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11942418 ↗
• MalfunctionMay 28, 2021Excess Flow or Over-Infusion; Infusion or Flow Problem; Excess Flow or Over-Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE, A SMITHS MEDICAL CADD ADMINISTRATION SET WAS OVER DELIVERING. IT WAS REPORTED THAT 13.5 HOURS SHOULD HAVE BEEN REMAINING, BUT THE BAG WAS NOTED TO BE EMPTY. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901263 ↗
• MalfunctionFeb 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE LEAKED WHEN CONNECTED TO A WALKMED IV BAG (ITEM IPR150). NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11343675 ↗
• MalfunctionJul 24, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PUMP ALARMED AT 5:30 AND WAS DUE TO BE DISCONNECTED AT 11:30. THE BAG WAS FOUND TO BE COMPLETELY DRY. THERE WAS NO MEDICATION RESIDUE ON THE PUMP. THE UPSTREAM SENSOR WAS ON AND THE PATIENT WAS NOT AFFECTED AT THIS TIME. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320659 ↗