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CADD 21-7324-24Recalls & reported problems

Icu Medical, Inc. · Class 2

All models of CADD (123)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This ICU Medical CADD infusion set is tubing used with CADD pumps to deliver medicine. Many reports describe too little medicine being delivered because of blocked tubing, and some describe leaks or lost pain relief. The 157 reports include no deaths and 2 injuries. Two open recalls name this device, covering tubing blockages that cause under-delivery and false no-disposable alarms. Reports fell from 20 in the prior 12 months to 10 in the latest 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
155
Deaths reported
0
Injuries reported
2
Recalls naming it
2

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 10610586029653), received between Jun 2, 2017 and May 21, 2026 — classified as 2 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (48 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 other recalls cover devices cleared under the same FDA submission (K040636); 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 18, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 6 reportsAug 2024: 2 reportsSep 2024: 4 reportsOct 2024: 3 reportsNov 2024: 3 reportsDec 2024: 2 reportsJan 2025: 2 reportsFeb 2025: 4 reportsMar 2025: 4 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 4 reportsDec 2025: 1 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Dec 9, 2022Class IOpen, Classified

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Z-0963-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Dec 9, 2022Class IOpen, Classified

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Z-0966-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Insufficient Flow or Under Infusion48
  • Failure to Infuse21
  • Fluid/Blood Leak18
  • Obstruction of Flow17
  • Infusion or Flow Problem11
  • Inaccurate Delivery9
  • Air/Gas in Device6
  • Detachment of Device or Device Component5

Patient problems

  • No Clinical Signs, Symptoms or Conditions82
  • No Consequences Or Impact To Patient30
  • No Information20
  • Insufficient Information14
  • No Patient Involvement12
  • Pain12
  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 25 most recent of 155 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 21, 2026Obstruction of Flow

    IT WAS REPORTED THAT THEY ENCOUNTERED A CADD EPIDURAL PUMP SCENARIO WHERE THE PUMP APPEARED TO FUNCTION NORMALLY, CYCLING AND LOGGING DOSES AS DELIVERED AND NO FLUID WAS ACTUALLY LEAVING THE BAG, RESULTING IN LOSS OF ANALGESIA. IT REQUIRED MULTIPLE PHYSICIAN HAND BOLUSES AND AN EPIDURAL CATHETER REPLACEMENT BEFORE THE PUMP ISSUE WAS IDENTIFIED. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25242730 ↗
  • MalfunctionFeb 5, 2026Air/Gas in Device

    IT WAS REPORTED THAT THE NURSE OBSERVED THE PRESENCE OF AIR IN THE TUBING. THERE WAS NO INJURY OR MEDICAL INTERVENTION. THE SYRINGE PUMP WAS STOPPED AND THE TUBING WAS REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24268370 ↗
  • MalfunctionJan 13, 2026Fluid/Blood Leak

    IT WAS REPORTED THAT ON AN EPIDURAL CATHETER IN L1-L2, THEY FOUND A LEAK AT THE LEVEL OF THE TUBING NEAR THE THREAD CONNECTION WITH THE FILTER. DATE OF INSTALLATION WAS ON (B)(6) 2025. IMMEDIATE ACTIONS WERE STOPPING THE SYRINGE PUMP AND REMOVING THE EPIDURAL CATHETER 24 HOURS BEFORE THE PRESCRIBED DATE. IMMEDIATE APPARENT CONSEQUENCES FOR THE PATIENT WERE DISCONTINUATION OF THE ADMINISTRATION OF ANALGESICS WITH A RISK OF UNCONTROLLED ANALGESIA IN A 13-MONTH-OLD CHILD, POTENTIAL INFECTIOUS RISK DUE TO THE RUPTURE OF THE CLOSED SYSTEM AND RISK OF GAS EMBOLISM WITH PROBABLE AIR ENTRY INTO THE SYSTEM. THE INCIDENT WAS REPORTED TO ANSM. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24060605 ↗
  • MalfunctionDec 30, 2025Complete Blockage; Complete Blockage

    IT WAS STATED THAT WHEN CONNECTING TO THE INFUSION, THE MEDICATION DOES NOT FLOW INTO THE TUBING, AND IT SEEMS BLOCKED. THERE WAS PATIENT INVOLVEMENT/ NO ADVERSE EVENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23923138 ↗
  • MalfunctionNov 20, 2025Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT DURING AN OBSTETRIC EPIDURAL PLACEMENT WITHOUT ISSUE, A FAILURE TO ADMINISTER A PHYSICIAN BOLUS USING THE PUMP (PCEA MACHINE) WAS NOTICED DUE TO A 'DOWNSTREAM OCCLUSION' ALARM, DESPITE NO DIFFICULTY PERFORMING A MANUAL SYRINGE INJECTION. CHANGING THE PUMP, IT WAS THE SAME PROBLEM. CHANGING THE INFUSION CASSETTE THE ISSUE WAS RESOLVED. THE REPORTER SAYS THAT THE PROBLEM WAS RECURRING, IT HAPPENED THREE TIMES DURING THE LAST TWO 24-HOUR SHIFTS. CHANGING THE CASSETTE CAUSED A LOSS OF TIME AND DELAYS IN MANAGING THE PATIENT'S PAIN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23606825 ↗
  • MalfunctionNov 20, 2025Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT DURING AN OBSTETRIC EPIDURAL PLACEMENT WITHOUT ISSUE, A FAILURE TO ADMINISTER A PHYSICIAN BOLUS USING THE PUMP (PCEA MACHINE) WAS NOTICED DUE TO A 'DOWNSTREAM OCCLUSION' ALARM, DESPITE NO DIFFICULTY PERFORMING A MANUAL SYRINGE INJECTION. CHANGING THE PUMP, IT WAS THE SAME PROBLEM. CHANGING THE INFUSION CASSETTE THE ISSUE WAS RESOLVED. THE REPORTER SAYS THAT THE PROBLEM WAS RECURRING, IT HAPPENED THREE TIMES DURING THE LAST TWO 24-HOUR SHIFTS. CHANGING THE CASSETTE CAUSED A LOSS OF TIME AND DELAYS IN MANAGING THE PATIENT'S PAIN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23605771 ↗
  • MalfunctionNov 20, 2025Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT DURING AN OBSTETRIC EPIDURAL PLACEMENT WITHOUT ISSUE, A FAILURE TO ADMINISTER A PHYSICIAN BOLUS USING THE PUMP (PCEA MACHINE) WAS NOTICED DUE TO A 'DOWNSTREAM OCCLUSION' ALARM, DESPITE NO DIFFICULTY PERFORMING A MANUAL SYRINGE INJECTION. CHANGING THE PUMP, IT WAS THE SAME PROBLEM. CHANGING THE INFUSION CASSETTE THE ISSUE WAS RESOLVED. THE REPORTER SAYS THAT THE PROBLEM WAS RECURRING, IT HAPPENED THREE TIMES DURING THE LAST TWO 24-HOUR SHIFTS. CHANGING THE CASSETTE CAUSED A LOSS OF TIME AND DELAYS IN MANAGING THE PATIENT'S PAIN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23605768 ↗
  • MalfunctionNov 12, 2025Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED THAT OCCLUSION DURING PURGING AND IN THE MIDDLE OF INFUSION: ONLY ONE CONSUMABLE WAS SET ASIDE. THERE WAS NO IMPACT FOR THE PATIENT BECAUSE THE PUMP AND THE CONSUMABLE HAVE BEEN CHANGED. THERE WAS PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23534442 ↗
  • MalfunctionAug 29, 2025Failure to Disconnect; Failure to Disconnect

    IT WAS REPORTED THAT SINCE THE SWITCH FROM EPIDURAL CADD CASSETTES TO CADD ADAPTOR TUBING WITH BAGS ABOUT A MONTH AGO, THERE HAVE BEEN SEVERAL INSTANCES WHERE NURSING STAFF WERE UNABLE TO DISCONNECT THE LUER LOCK END OF THE EPIDURAL TUBING FROM THE EPIDURAL FILTER. A PHOTO FROM THE EDUCATION EPIDURAL LINE WAS INCLUDED FOR REFERENCE. THE CONNECTION HAS BEEN DESCRIBED AS OVERLY TIGHTENED, WITH SOME ATTRIBUTING THE ISSUE TO PRESSURE OR FLUID BUILDUP AT THE CONNECTION POINT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22927131 ↗
  • MalfunctionAug 6, 2025Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED THAT THE DEVICE HAD A DOWNSTREAM OCCLUSION DURING PRIMING. THE INCIDENT WAS NOTICED OVER THE PAST SEVERAL MONTHS WITH SEVERAL DIFFERENT BATCHES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22726668 ↗
  • MalfunctionJul 28, 2025Loose or Intermittent Connection; Obstruction of Flow; No Flow; Loose or Intermittent Connection; Obstruction of Flow; No Flow

    IT WAS REPORTED THAT THE PUMP HAD NO FLOW AND EXHIBITED A PRESSURE ALARM. THE REPORTER NOTED THAT IT WAS NOT POSSIBLE TO VENTILATE THE PATIENT LINE BECAUSE THE PUMP CONSTANTLY TRIGGERED THE PRESSURE ALARM. THE RESERVOIR WAS NOT PROPERLY TIGHT, WAS MISALIGNED AND GAVE PRESSURE ALARM. IT WAS FURTHER NOTED THAT THE INFUSION SETS WERE PROBABLY NOT COMPLETELY LOCKED TO THE PUMP AND THEREFORE TRIGGERED AN ALARM DUE TO ITS MOBILITY. THE SETS FROM THIS BATCH WERE USED ON SEVERAL PUMPS AND THE PROBLEM WAS REPRODUCED IN EACH CASE. SETS OF OTHER BATCHES EACH RAN WITHOUT ERRORS. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM/ADVERSE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22631891 ↗
  • MalfunctionJul 25, 2025Complete Blockage; Complete Blockage

    IT WAS REPORTED THAT NO LIQUID WAS GOING THROUGH THE TUBE. AT A CLOSER LOOK IT COULD BE SEEN THAT THE TUBE WAS PINCHED FLAT. BECAUSE OF THIS, NO LIQUID COULD PASS. THEY REMOVED THE INFUSION SET AND TOOK A NEW ONE THAT WORKED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22614123 ↗
  • MalfunctionJun 4, 2025Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow

    IT WAS REPORTED THAT THE TUBING HAD BEEN UNABLE TO BE PRIMED USING THE CADD PUMP; THE PUMP READ "UPSTREAM OCCLUSION." DESPITE THE TUBING BEING RESEATED AND THE BAG BEING APPROPRIATELY SPIKED, THE ISSUE PERSISTED. A SECOND TUBING HAD TO BE USED, WHICH WORKED. THE EVENT OCCURRED DURING PRIMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22143945 ↗
  • MalfunctionMar 24, 2025Failure to Infuse; Infusion or Flow Problem; Air/Gas in Device; Failure to Infuse; Infusion or Flow Problem; Air/Gas in Device

    IT WAS REPORTED THAT THERE WERE CHALLENGES USING THE ADMINISTRATION SET WHILE PROPERLY SPIKING THE MEDICATION BAG. THE PUMP APPEARED FUNCTIONAL, HOWEVER THE MEDICATION DID NOT INFUSED AND THE AIR WAS PRESENT IN THE LINE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM OR ADVERSE EVENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21682825 ↗
  • MalfunctionMar 24, 2025Failure to Infuse; Infusion or Flow Problem; Air/Gas in Device; Failure to Infuse; Infusion or Flow Problem; Air/Gas in Device

    IT WAS REPORTED THAT THERE WERE CHALLENGES USING THE ADMINISTRATION SET WHILE PROPERLY SPIKING THE MEDICATION BAG. THE PUMP APPEARED FUNCTIONAL, HOWEVER, THE MEDICATION DID NOT INFUSE, AND AIR WAS PRESENT IN THE LINE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM OR ADVERSE EVENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21681940 ↗
  • MalfunctionMar 21, 2025Air/Gas in Device; Air/Gas in Device

    IT WAS REPORTED THAT THERE WERE DIFFICULTIES SPIKING A BAG WITH THE CADD ADMINISTRATION SET, AND THAT THE BAG COULD NOT BE FULLY SPIKED, CAUSING AIR TO ENTER THE SYSTEM. IT ALSO HAD DIFFICULTIES REMOVING AN EXISTING BAG SPIKED WITH ANESTHESIA AND SPIKING A NEW BAG, ALONG WITH ISSUES RELATED TO AIR ACCUMULATING IN THE TUBING. IT WAS NOTED THAT WHILE THE PUMP APPEARED TO BE OPERATING, THE LINE WAS NOT FULLY SPIKED, WHICH PREVENTED THE DRUG FROM INFUSING. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21665297 ↗
  • MalfunctionMar 6, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

    IT WAS REPORTED THAT A SECTION OF THE CASSETTE SPLIT AND THERE WAS SUBSEQUENT LEAKING OF THE EPIDURAL SOLUTION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21540230 ↗
  • MalfunctionFeb 7, 2025Complete Blockage; Failure to Infuse; Obstruction of Flow; Complete Blockage; Failure to Infuse; Obstruction of Flow

    IT WAS REPORTED THAT ¿THE DRUG COULD NOT BE ADMINISTERED TO THE PATIENT DUE TO A BLOCKED TUBING (CLAMPED)." THERE WAS PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21337443 ↗
  • MalfunctionFeb 4, 2025Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT WHEN THE TUBING IS PLACED ON THE PUMP, EVERYTHING IS ALRIGHT, THEN VALIDATION OF THE PARAMETERS IS ALRIGHT, THE START OF THE PURGE IS ALRIGHT, THEN AFTER 2 MINUTES THE PUMP RINGS AND THE ALARMS DETECT AN OCCLUSION. THE REPORTED ISSUE OCCURRED JUST BEFORE USE WITH THE PATIENT. NO CLINICAL CONSEQUENCES EXCEPT THAT THE PATIENT DID NOT HAVE THE OPTIMAL ANALGESIA. THE PUMP WAS CHANGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21309072 ↗
  • MalfunctionFeb 4, 2025Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT AT THE DELIVERY ROOM, EQUIPMENT IS DEFECTIVE AND INDICATES AN OCCLUSION. THE PCEA IS THEREFORE ON ALERT AND DOES NOT STOP RINGING. THE DEFECT IN THE REPORTED PRODUCT OCCURRED WHEN USED WITH A PATIENT, BUT WITHOUT CLINICAL OR PATIENT INJURY. THE EVENT WAS RESOLVED BY CHANGING THE DEVICE. NO INFORMATION AVAILABLE ABOUT THE PATIENT, ONLY THAT THE PATIENT IS A WOMAN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21308865 ↗
  • MalfunctionFeb 4, 2025Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT WHEN THE TUBING IS PLACED ON THE PUMP, EVERYTHING IS ALRIGHT, THEN VALIDATION OF THE PARAMETERS IS ALRIGHT, THE START OF THE PURGE IS ALRIGHT, THEN AFTER 2 MINUTES THE PUMP RINGS AND THE ALARMS DETECT AN OCCLUSION. THE REPORTED ISSUE OCCURRED JUST BEFORE USE WITH THE PATIENT. NO CLINICAL CONSEQUENCES EXCEPT THAT THE PATIENT DID NOT HAVE THE OPTIMAL ANALGESIA. THE PUMP WAS CHANGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21304732 ↗
  • MalfunctionJan 17, 2025Obstruction of Flow; Obstruction of Flow

    THE PATIENT REPORTED THAT WHILE IN LABOR THE DOCTOR ATTEMPTED EPIDURAL FOUR TIMES AND PATIENT NEVER EXPERIENCED PAIN RELIEF; CONTINUED TO RATE PAIN 10/10. A NEW EPIDURAL WAS PLACED BY A CERTIFIED REGISTERED NURSE ANESTHETIST. SHE ALSO CHANGED OUT TUBING AND EPIDURAL BAG. WHEN CHANGING THE EPIDURAL TUBING, IT WAS NOTICED THAT THE MEDICATION WAS NOT INFUSING THROUGH THE EPIDURAL TUBING LIKE IT SHOULD. AFTER THIS LAST ATTEMPT THE PATIENT WAS COMFORTABLE, AND HER PAIN WAS 0/10 FOR DELIVERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21182153 ↗
  • MalfunctionJan 14, 2025Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT THE TUBING WAS NOT DELIVERING THE MEDICATION. REPORTER STATED THE PATIENT WAS INITIALLY COMFORTABLE AFTER RECEIVING THE EPIDURAL, BUT APPROXIMATELY ONE HOUR LATER STATED THAT THE PAIN HAD RETURNED TO THE LEVEL BEFORE THE EPIDURAL, DESPITE MULTIPLE ATTEMPTS TO USE THE EPIDURAL BOLUS BUTTON. THE ANESTHESIOLOGIST USED ICE CUBES TO TEST THE PATIENT'S EPIDURAL LEVEL, AND THE PATIENT FELT COLD ICE ON EVERY LEVEL OF THE BODY, SO THE DOCTOR PROCEEDED WITH REPLACING THE EPIDURAL. AFTER THE SECOND EPIDURAL PLACEMENT, THE SAME SITUATION OCCURRED: THE PATIENT WAS INITIALLY COMFORTABLE, BUT THE EPIDURAL QUICKLY WORE OFF AGAIN. DURING THE BEDSIDE ASSESSMENT, IT WAS NOTICED THAT DESPITE HOURS OF A RUNNING EPIDURAL, THE FENTANYL BAG HANGING IN THE LOCKED BOX REMAINED COMPLETELY FULL. THE DOCTOR DISCONNECTED THE TUBING AND TESTED THE EPIDURAL BOLUS BUTTON, DISCOVERING THAT NOTHING WAS COMING OUT OF THE TUBING AND THE PATIENT HAD NOT BEEN RECEIVING ANY MEDICATION. THE DOCTOR REPLACED THE EPIDURAL TUBING, MANUALLY BOLUSED THE PATIENT WITH 10ML OF 0.25%, AND RECONNECTED THE CONTINUOUS INFUSION. THE EPIDURAL FUNCTIONED PROPERLY AFTER THIS TUBING REPLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21148011 ↗
  • MalfunctionDec 27, 2024Insufficient Flow or Under Infusion; Failure to Infuse; Insufficient Flow or Under Infusion; Failure to Infuse

    IT WAS STATED THAT EITHER THE EPIDURAL PUMP TUBING OR PUMP OR BOTH MALFUNCTIONED 7 HOURS INTO THE EPIDURAL RUNNING APPROPRIATELY. EPIDURAL STARTED AT 0748 AND RAN WELL WITH NO ISSUES, PATIENT HAD NO PAIN. AT 1417, NEW BAG WAS HUNG DUE TO LOW RESERVOIR VOLUME. AT THIS TIME, PATIENT PAIN WAS INCREASING AND RN NOTICED THAT ABOUT HALF OF THE BAG WAS STILL FULL RATHER THAN THE SMALLER AMOUNT OF RESERVOIR VOLUME THAT THE PUMP STATED. THE PUMP THEN ALARMED THAT THERE WAS AN OCCLUSION AND AIR IN THE LINE WHEN THERE WAS NO OCCLUSION OR AIR. WITH THE PATIENTS INCREASE IN PAIN, THE INCREASE IN RESERVOIR VOLUME FROM WHAT THE PUMP SAID, THE OCCLUSION AND AIR IN LINE WHICH WAS NOT ACCURATE, THE PUMP AND PUMP TUBING WAS REPLACED IMMEDIATELY. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21028745 ↗
  • MalfunctionDec 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE TUBING WAS PLACED IN THE CADD PUMP TO PRIME THE TUBING, AND THE MEDICATION WAS LEAKING OUT THE SIDE BY THE BLACK CLIP. THE PRODUCT FAULT OCCURRED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20904542 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040636. One submission often covers many models, so check the product and lot details in each record.

  • Z-2522-2025 · Aug 6, 2025 · Open, Classified
    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
  • Z-1767-2017 · Mar 17, 2017 · Terminated
    CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
  • Z-1831-2016 · Apr 22, 2016 · Terminated
    CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24
  • Z-1286-2015 · Feb 2, 2015 · Terminated
    CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
  • Z-0879-2008 · Dec 14, 2007 · Terminated
    Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Pa

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Sources and updates

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