CADD 21-7359-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 10610586027406), received between Aug 4, 2017 and May 18, 2026 — classified as 110 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (36 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.

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

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Failure to Deliver; Obstruction of Flow

  IT WAS REPORTED THAT THE ANTIBIOTICS INFUSION WAS NOT DELIVERED VIA THE CADD PUMP AS INTENDED. THE CADD PUMP WAS SET TO GIVE ANTIBIOTICS OVER 24 HOURS. WHEN THE PUMP WAS DISCONNECTED, AS PLANNED, IT WAS DISCOVERED THAT THE INFUSION BAG WAS STILL FULL. THE PUMP WAS SET CORRECTLY AND WAS SET TO A RESERVOIR VOLUME OF 0 ML. THE PUMP WAS SUBSEQUENTLY CHECKED IN THE MEDICAL TECHNOLOGY DEPARTMENT AND IT WAS WORKING AS IT SHOULD. THE SUSPICION FELL ON THE INFUSION SET. THE RESULT OF THE EVENT NECESSITATED MEDICAL OR SURGICAL TREATMENT AND IT ALSO CAUSED A DELAY IN TREATMENT. THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209793 ↗
• MalfunctionMar 16, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT FOUND HIS TUBING WAS DISCONNECTED. PUMP HAD ALREADY STOPPED. THE LEAK OCCURRED NEAR LUER. THERE WAS NO PATIENT HARM OR INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605119 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PUMP ALARMED FOR AIR-IN-LINE. THE PATIENT ACKNOWLEDGED THE ALARM AND ATTEMPTED TO RESTART THE PUMP WITHOUT SUCCESS, THEN REPORTED THAT THE PUMP CASE AND CLOTHING WERE WET AND THAT THE TUBING HAD SEPARATED NEAR THE PUMP. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209508 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP ALARMED AIR-IN-LINE. PER REPORTER, THE PATIENT HAD ACKNOWLEDGED THE ALARM PRIOR TO CALLING AND ATTEMPTED A RESTART WITHOUT SUCCESS AND SUBSEQUENTLY FOUND THAT THEIR CLOTHING WAS WET AND THE TUBING HAD SEPARATED NEAR THE PUMP. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168716 ↗
• MalfunctionJan 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT UPON INSPECTION OF THE TUBING AND SETUP, THERE WAS A CLEAR BREAK IN THE SEAL AT THE JUNCTION OF THE TUBING ON THE WALKMED BAG AND THE LEUR LOCK. THE PICTURE BELOW WAS NOT GREAT, BUT IT GIVES THE IDEA OF WHERE THE BREAK WAS. WHEN THEY PUSHED THE FLUID THROUGH THE TUBING, THERE WAS AN OBVIOUS LOSS OF FLUID, THEY FELT CONFIDENT THAT THIS OCCURRED AFTER IT WAS MADE AND DELIVERED TO ONCOLOGY. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED IMMEDIATELY ON USE. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081204 ↗
• MalfunctionDec 16, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT WENT FOR PUMP DISCONNECTION AND WHILE THE PUMP SHOWED THAT THE FULL VOLUME HAD BEEN INFUSED, MORE THAN HALF OF THE VOLUME WAS STILL IN THE BAG. THE AMOUNT OF MEDICATION REMAINING IN THE CASSETTE DID NOT MATCH THE RESERVOIR VOLUME DISPLAYED ON THE PUMP. THE PATIENT DID NOT RECEIVE FULL DOSE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819005 ↗
• MalfunctionDec 15, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE EXHIBITED AN "UPSTREAM OCCLUSION¿ WHEN THE ADMINISTRATION SET HAD BEEN USED WITH A 150 ML BAG. NO ISSUES HAD BEEN OBSERVED WHEN THE 50 ML OR 100 ML HARD CASSETTES HAD BEEN USED. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803622 ↗
• MalfunctionNov 5, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PATIENT CAME FOR DISCONNECT BUT THE PUMP FINISHED APPROXIMATELY 6 HOURS EARLY. THE PUMP SHOWS THAT THERE WAS DRUG LEFT IN THE RESERVOIR BAG, BUT IT WAS COMPLETELY DRY. A CONTINUOUS INFUSION RATE OF 3 ML/HOUR HAD BEEN PROGRAMMED, WITH A TOTAL RESERVOIR VOLUME OF 15 ML AND GIVEN 100 PERCENT OF DOSE BUT BAG WAS BONE DRY. THE AMOUNT OF MEDICATION REMAINING IN THE 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. THERE WAS NO AMOUNT REMAINING, BUT IT SAID THERE WAS 15 ML LEFT IN THE BAG. THE AIR DETECTOR AND THE UPSTREAM SENSOR HAD BEEN TURNED ON. THE LENGTH OF THE INFUSION INTENDED HAD BEEN SET TO 46 HOURS. THE LENGTH OF ACTUAL INFUSION HAD BEEN SET TO 38-40 HOURS, BUT IT WAS FINISHED EARLY. A CSTD WAS USED TO FILL THE CASSETTE. THE PUMP WAS NOT USED TO PRIME THE EXTENSION TUBING. THE LINE WAS PRIMED USING THE SYRINGE. THE CSTD MANUFACTURER WAS BD. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. ASSOCIATED CASSETTE COMPLAINT DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478662 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UPON STARTING CHEMOTHERAPY TREATMENT AND CONNECTING THE INFUSION HOSES TO CADD INFUSION PUMPS, IT WAS DISCOVERED THAT THE INFUSION HOSE ON ONE OF THE CHEMO PREPARATIONS HAD BROKEN AT THE CONNECTION TO THE INFUSION BAG. THE CHEMO HAD THEREFORE LEAKED INTO THE YELLOW BOX IN WHICH THE CHEMO TO THE PATIENT IS NORMALLY CARRIED. IT IS UNKNOWN HOW MUCH OF THE DOSE HAD LEAKED OUT OF THE BAG, AND THE OTHER INFUSION BAGS WERE CONTAMINATED WITH CHEMO. THE TREATMENT WAS POSTPONED UNTIL THE NEXT DAY, WHEN NEW CHEMO WOULD HAVE BEEN OBTAINED. THERE WAS PATIENT INVOLVEMENT. CONSEQUENCES WERE AVOIDED BECAUSE INTERVENTION HAD OCCURRED. THE INCIDENT HAS BEEN REPORTED TO THE DANISH REGULATORY AGENCY, NCA REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004497 ↗
• MalfunctionSep 5, 2025Failure to Infuse; Obstruction of Flow; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE HAD ALARMED WITH A DISTAL OCCLUSION ERROR. IT HAD BEEN UNCLEAR WHETHER THE ISSUE HAD BEEN RELATED TO THE PUMP ITSELF OR THE TUBING. AFTER THE LINE HAD BEEN REPRIMED INTO NEW TUBING AND CONNECTED TO A NEW PUMP, THE ERROR HAD BEEN RESOLVED. THE CONTINUOUS INFUSION RATE HAD BEEN 3 ML/HR, WITH A STARTING RESERVOIR VOLUME OF 144 ML AND A REMAINING VOLUME OF 143.5 ML. THE PATIENT HAD NOT BEEN MEDICALLY AFFECTED BY THE ISSUE. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984285 ↗
• MalfunctionSep 3, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT UPON WAKING, THE PATIENT HAD DISCOVERED THAT THE NEEDLE HAD DISLODGED, RESULTING IN CHEMO LEAKING ONTO HIS SKIN AND BEDDING. HE HAD TURNED OFF THE PUMP, PLACED ALL CONTAMINATED MATERIALS IN A BIOHAZARD BAG, AND HAD IMMEDIATELY WASHED THE AFFECTED SKIN THOROUGHLY WITH SOAP AND WATER. HIS CLOTHES HAD BEEN LAUNDERED SEPARATELY. THE CONTINUOUS INFUSION RATE HAD BEEN SET AT 105 ML/HR, WITH A STARTING RESERVOIR VOLUME OF 200 ML. THE REMAINING RESERVOIR VOLUME HAD BEEN UNABLE TO BE MEASURED. THE AIR DETECTOR HAD BEEN OFF, WHILE THE UPSTREAM SENSOR HAD BEEN ON. THE INFUSION HAD BEEN INTENDED TO RUN FOR 46 HOURS BUT HAD BEEN CUT SHORT. THE LOCK LEVEL HAD BEEN SET TO 2. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING. INSTEAD, THE LINE HAD BEEN PRIMED PRIOR TO ATTACHING THE BAG TO THE PUMP. THE PATIENT HAD BEEN MEDICALLY AFFECTED, HAVING RECEIVED LESS MEDICATION THAN PRESCRIBED, ALTHOUGH THE EXACT AMOUNT COULD NOT BE DETERMINED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952117 ↗
• MalfunctionAug 20, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT¿S TUBING HAD BECOME DISCONNECTED NEAR THE PORT AND HAD BEEN RECONNECTED BY THE PATIENT. PER REPORTER, SOME BLOOD HAD LEAKED FROM THE PORT AND THAT BLOOD HAD BEEN VISIBLE IN THE TUBING. PUMP SETTINGS HAD BEEN OBTAINED, AND THE PUMP HAD BEEN POWERED DOWN. CHEMOTHERAPY SPILL INSTRUCTIONS HAD BEEN PROVIDED. IN ACCORDANCE WITH SPECIAL FACILITY INSTRUCTIONS, THE PATIENT HAD BEEN INSTRUCTED TO CONTACT THE FACILITY AND SPEAK WITH THE PROVIDER ON CALL. IT HAD BEEN EXPLAINED THAT THE PORT NEEDED TO BE FLUSHED DUE TO THE PRESENCE OF BLOOD IN THE TUBING. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849526 ↗
• MalfunctionAug 19, 2025Insufficient Flow or Under Infusion; Failure to Deliver; Insufficient Flow or Under Infusion; Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT HAD GONE HOME WITH THE DEVICE, BUT NO MEDICATION HAD BEEN INFUSED, AND NO ALARMS HAD BEEN TRIGGERED. IT HAD BEEN STATED BY THE COMPANY REPRESENTATIVE THAT THE UPSTREAM SENSORS ON THEIR DEVICE HAD NOT BEEN ACTIVATED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838894 ↗
• MalfunctionJul 14, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE HAD BEEN NO MEDICATION REMAINED IN THE BAG, DESPITE THE PUMP INDICATING THAT 8.7 ML WAS STILL REMAINING. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500972 ↗
• MalfunctionJul 14, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PUMP HAD COMPLETED INFUSION 5 HOURS EARLIER THAN EXPECTED. ALTHOUGH NO MEDICATION HAD BEEN LEFT IN THE BAG, THE PUMP HAD INDICATED THAT 8.7 ML REMAINED. THE PATIENT HAD RECEIVED ALL THE MEDICATION CONTAINED IN THE BAG. THE CONTINUOUS INFUSION RATE HAD BEEN SET TO 3 ML/HR, WITH A TOTAL RESERVOIR VOLUME OF 138 ML. THE PUMP HAD RECORDED 124.10 ML AS DELIVERED. THE AIR DETECTOR HAD BEEN TURNED OFF, WHILE THE UPSTREAM SENSOR HAD BEEN TURNED ON. THE TOTAL LENGTH OF THE INFUSION HAD BEEN 46 HOURS, AND THE LOCK LEVEL HAD BEEN SET TO 2. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING; INSTEAD, IT HAD BEEN MANUALLY PRIMED WITH NORMAL SALINE. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500747 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PUMP HAD LEAKED. THE ENTIRE BAG HAD LEAKED OUT OVERNIGHT. THE SOURCE OF THE LEAK HAD BEEN UNDETERMINED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341451 ↗
• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP BECAME CONTAMINATED WITH 5FU AFTER MEDICATION LEAKED ALL OVER IT WHILE IN THE POUCH. PER REPORTER, THEY HAD IT ON LONGER DUE TO THE PUMP HAVING STOPPED RUNNING FOR A FEW HOURS, AND THEREFORE IT WAS BEHIND SCHEDULE. REPORTER STATED THEY NOTICED THE TUBING LOOKED EMPTY AND THEN NOTICED THE BAG OF 5FU WAS EMPTY AND THAT IT HAD LEAKED EVERYWHERE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309345 ↗
• MalfunctionJun 12, 2025Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  IT WAS REPORTED THAT A CADD ADMINISTRATION SET (69", M/M, FS, TOTM, 12/BX, ITEM #21-7359-24) WAS IN USE WHEN THE PUMP ALARMED FOR AN UPSTREAM OCCLUSION MULTIPLE TIMES. ALTHOUGH THE INFUSION WOULD BRIEFLY CONTINUE, THE ALARM WOULD REOCCUR SEVERAL SECONDS LATER. THIS WAS THE SECOND OCCURRENCE FOR THE SAME PATIENT, BOTH INCIDENTS HAPPENING ON DISCONNECT DAY. AT THE TIME OF THE EVENT, 3.4 ML OF VOLUME REMAINED (EQUIVALENT TO 1 HOUR AND 33 MINUTES OF INFUSION) THE TUBING IS AVAILABLE FOR RETURN ALONG WITH THE PUMP. THE EVENT OCCURRED WHILE THE DEVICE WAS IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196638 ↗
• MalfunctionFeb 11, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP WAS ALARMING DOWNSTREAM OCCLUSION REPETITIVELY AND PATIENT EXPERIENCED A CHEMO SPILL. NEEDLE REMOVED FROM PORT AND PATIENT DISCHARGED. PATIENT CAME IN FOR PORT SITE ASSESSMENT, PORT SITE WAS RED AND IRRITATED NO KNOWN HARM FOR PATIENT. PATIENT DID NOT RECEIVE INTENDED DOSE. DRUG BEING INFUSED WAS FLUOROURACIL. CONTINUOUS INFUSION RATE WAS 3 ML/HR. RESERVOIR VOLUME: ORIGINAL VOLUME TO BE INFUSED WAS 138 ML. GIVEN WAS 108 ML. LENGTH OF INFUSION: INTENDED 46 HOURS. LOCK LEVEL WAS UNKNOWN. A CLOSED SYSTEM DRUG-TRANSFER DEVICE WAS USED TO FILL CASSETTE. THE PUMP WAS USED TO PRIME THE EXTENSION TUBING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. POSSIBLE LOT NUMBERS 6037654, 6026751, 6005535.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358999 ↗
• MalfunctionFeb 5, 2025Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PUMP EXHIBITED AN ALARM BUT CONTINUED TO WORK WITHOUT AN ERROR. THE CONTINUOUS INFUSION RATE WAS 3 ML/HR, WITH A TOTAL RESERVOIR VOLUME OF 138 ML. THE PUMP INDICATED THAT 125.90 ML HAD BEEN GIVEN, BUT THE BAG HAD BEEN EMPTY, WITH 12.1 ML REMAINING. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316594 ↗
• MalfunctionJan 10, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP EXHIBITED A CHECK FOR EMPTY TUBING RESERVOIR MESSAGE. TROUBLESHOOTING WAS PERFORMED AND THE PUMP CONTINUED TO ALARM. THE CONTINUOUS INFUSION RATE WAS 3 ML/HR, WITH A TOTAL RESERVOIR VOLUME OF 140 ML, AND 45.8 ML WAS GIVEN. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129982 ↗
• MalfunctionDec 27, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT AN ERROR CODE ALARM MESSAGE WAS TRIGGERED, WHICH WAS AFFECTING A PATIENT. THE PATIENT REPORTED THAT THE PUMP BEGAN BEEPING 7 HOURS AFTER CONNECTION, DISPLAYING AN UNKNOWN ERROR MESSAGE. AS A RESULT, THE PATIENT HAD TO VISIT THE MEDICAL FACILITY EARLY TO RECEIVE A NEW INFUSION BAG. THE STAFF REASSIGNED A NEW PUMP, BUT THE PATIENT MISSED THE REMAINING DOSE FROM THE INITIAL BAG. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029642 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STUD IN THE HARD PLASTIC BROKE AND THAT THE MEDICINE LEAKED OUT OF THE CASSETTE. THE PATIENT DID NOT RECEIVE ALL THE PRESCRIBED MEDICATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857241 ↗
• MalfunctionDec 2, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR CADD DISCONNECTION AROUND 1610H. HOWEVER, AN ALARM FOR OCCLUSION OCCURRED EARLIER IN DAY BUT THEN STOPPED ALARMING WHEN PATIENT ADJUSTED THE TUBING. THE PUMP RESERVOIR INDICATED 12.1 ML LEFT TO INFUSE AT AROUND 1430. HOWEVER, BAG WAS EMPTY. THE PUMP ALARMED AND THE SCREEN DISPLAYED AN ¿OCCLUSION¿ MESSAGE. THE CONTINUOUS INFUSION RATE WAS 3 ML/HR. THE TOTAL RESERVOIR VOLUME WAS 138 ML. THE SCHEDULED INFUSION LENGTH WAS 46 HOURS, BUT IT FINISHED IN APPROXIMATELY 44 HOURS. LOCK LEVEL WAS SET TO LL2. AN ONGUARD CSTD WAS USED TO FILL THE CASSETTE. THE EXTENSION TUBE WAS PRIMED WHILE COMPOUNDING IN A HOOD WITH ADDED SALINE FROM A SEPARATE BAG. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827536 ↗
• MalfunctionNov 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INCORRECT CADD ADMINISTRATION SET WITH MALE LUER, FLOW STOP, CLAMP, AND A ONE-WAY CHECK VALVE, LOT NUMBER 6037654, INSTEAD OF A CADD ADMINISTRATION SET WITH A SPIKE. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800906 ↗

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