Ivenix, Inc. SET-0013-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00811505030054), received between Jul 3, 2024 and Jun 11, 2026 — classified as 3 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (37 reports).

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

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. Jun 24, 2025Class IIOpen, Classified

   Potential for external cassette leaks

   Z-2232-2025 · Root cause: Process design · Recall details · FDA record ↗

2. Aug 1, 2024Class IOpen, Classified

   A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

   Z-2721-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: ALARM- TUBING SET PROBLEM A PRELIMINARY REVIEW OF THE DEVICE LOGS WAS NOT PERFORMED. THE ADMINISTRATION SET WAS RETURNED FOR EVALUATION. THE SAMPLE WAS EVALUATED AND UNDERWENT A DETAILED 6M INVESTIGATION. VISUAL EXAMINATION IDENTIFIED A LEAK PATTERN NEAR THE SIDE CASSETTE AREA. HOWEVER, REPEAT FUNCTIONAL TESTING AND CONFIRMATION TESTING COULD NOT REPRODUCE THE REPORTED LEAK CONDITION. THE MANUFACTURING PROCESS, EQUIPMENT PARAMETERS, MATERIALS, AND METHODS WERE REVIEWED AND FOUND TO BE WITHIN VALIDATED SPECIFICATIONS. EXTENDED PRODUCTION DATA AND PROCESS VALIDATION RECORDS CONFIRMED THAT THE CASSETTE WELDING PROCESS REMAINS STABLE AND CAPABLE. BASED ON THE EVALUATION, THE REPORTED LEAK CONDITION AND ALARM IS CONFIRMED. THE INVESTIGATION IDENTIFIED EVIDENCE SUGGESTING A POTENTIAL LOCALIZED INNER CASSETTE LEAK ASSOCIATED WITH OVERHEATED PLASTIC DURING THE ULTRASONIC WELDING PROCESS, THEREFORE TRIGGERING THE TUBING SET PROBLEM ALARM. HOWEVER, REVIEW OF VALIDATED WELDING PARAMETERS, PRODUCTION RECORDS, AND ADDITIONAL PRODUCTION RUNS DEMONSTRATED THAT THE WELDING PROCESS WAS OPERATING WITHIN ESTABLISHED CONTROLS AND THAT NO SYSTEMIC MANUFACTURING ISSUE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473907 ↗
• MalfunctionApr 13, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: "LOT NUMBER FA25F16046. THE TUBING JUST CAME OUT OF THE DRIP TUBE. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: CONNECTION LEAK - SECONDARY PORT UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24863332 ↗
• MalfunctionApr 6, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "REPORT WAS RECEIVED FROM OUR NEWPORT NEWS OFFICE THAT THEY HAVE HAD MULTIPLE PRIMARY SETS FROM LOT # FA25F16046 WHERE "THE SECONDARY PORT ON THE CASSETTE IS COMING OFF WHEN EITHER REMOVING THE SYRINGE OR A SECONDARY TUBING." NO PATIENT OR STAFF INJURIES BECAUSE OF ANY OF THE FAILURES. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART) AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789275 ↗
• MalfunctionMar 23, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: "WE EXPERIENCED A LEAK WITH ONE OF OUR CASSETTES TODAY. THE UNIT WAS NOT DAMAGED BY OUR TEAM AND BEGAN LEAKING IMMEDIATELY UPON PRIMING." A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662791 ↗
• MalfunctionFeb 19, 2026Misassembled; No Apparent Adverse Event

  NO SAMPLE OR PICTURE AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. DUE TO THE ABSENCE OF A SAMPLE AND/OR BATCH TRACEABILITY INFORMATION, IT IS NOT POSSIBLE TO CONFIRM WHETHER THIS ISSUE ORIGINATED FROM THE MANUFACTURING PROCESS. THE POSSIBLE ROOT CAUSE OF A MISASSEMBLY WHERE THE Y-PORT WAS ASSEMBLED IN THE ROTATING LUER LOCK IS LIKELY ASSOCIATED WITH AN OPERATOR ERROR DURING THE ASSEMBLY PROCESS. AS A PREVENTIVE ACTION, ALL PERSONNEL ACROSS SHIFTS HAVE BEEN NOTIFIED OF THE CORRECT ASSEMBLY PROCEDURES RELATED TO THIS TYPE OF DEFECT. THE CURRENT PROCESS CONTROLS DETECTION INCLUDE 1) SAMPLING VISUAL INSPECTION PRE-POUCH SEALING AND FINAL PHYSICAL AREA, 2) 100% IN-PROCESS VISUAL INSPECTION: PERFORMED DURING THE MANUFACTURING PROCESS, 3) THE FIRST PIECE INSPECTION WILL BE PERFORMED TO THE FIRST FINAL ASSEMBLED KIT MANUFACTURED PER SHIFT. THIS KIT WILL BE SUBMITTED TO VISUAL INSPECTION AS PER THE CLASSIFICATION OF DEFECTS INCLUDED IN THIS SPECIFICATION AND AS PER THE APPLICABLE DRAWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389887 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: IVENIX TUBING LEAKING FLUID BETWEEN THE CARTRIDGE AND THE PIGGYBACK CONNECTION SITE. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THEREFORE, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. PROBABLE ROOT CAUSE OF REPORTED FAILURE COULD BE RELATED TO THE SUPPLIER MANUFACTURING PROCESS. IT IS POSSIBLE THAT A LEAK WAS DUE TO A LOOSE SECONDARY PORT CAUSED BY THE TIP OF K-ZERO NEEDLE-FREE LUER ACTIVATED VALVE BEING BROKEN CAUSING IT TO DETACH FROM THE SECONDARY PORT BASED ON PREVIOUS COMPLAINTS RECEIVED. A QUALITY ALERT WAS ISSUED TO THE PRODUCTION FLOOR TO PROVIDE OPERATOR AWAERENESS OF THIS COMPLAINT AND REINFORCE CURRENT WORK INSTRUCTION AT THE SUPPLIER. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058852 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: THE PATIENT STATED THAT SHE WAS SITTING IN HER CHAIR WHEN SHE REALIZED THAT SUDDENLY IT WAS "RAINING". NO CHEMO CAME INTO DIRECT CONTACT WITH THE PATIENT. BUT THE SPILL WAS DESCRIBED AS VERY LARGE BY THE PRIMARY NURSE. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. A VIDEO WAS PROVIDED BY THE CUSTOMER WHICH CONFIRMED THE REPORTED ISSUE. PROBABLE ROOT CAUSE OF REPORTED FAILURE COULD BE RELATED TO THE SUPPLIER MANUFACTURING PROCESS. IT IS POSSIBLE THAT A LEAK WAS DUE TO A LOOSE SECONDARY PORT CAUSED BY THE TIP OF K-ZERO NEEDLE-FREE LUER ACTIVATED VALVE BEING BROKEN CAUSING IT TO DETACH FROM THE SECONDARY PORT BASED ON PREVIOUS COMPLAINTS RECEIVED. A QUALITY ALERT WAS ISSUED TO THE PRODUCTION FLOOR TO PROVIDE OPERATOR AWARENESS OF THIS COMPLAINT AND REINFORCE CURRENT WORK INSTRUCTION AT THE SUPPLIER. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058851 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CASSETTE LEAKAGE COMPLAINTS. SEVERAL INSTANCES WITH NORMAL SALINE LEAKING FROM THE CASSETTE DURING PRIMING. NONE OF THE SETS WERE SAVED TO SEND IN FOR INVESTIGATION. THERE WAS ONE INCIDENCE OF A NURSE SETTING UP A CHEMO INFUSION AND BACK PRIMING THE SECONDARY SET, THEN REMOVING THE SET FROM THE SECONDARY INLET PORT AND "THE SECONDARY PORT ON THE CASSETTE SPRAYED HER WITH FLUID. SHE IMMEDIATELY WASHED HER NECK AND FACE." THE NURSE THAT EXPERIENCED A CHEMO SPILL TO THE FACE/NECK FROM THE SECONDARY INLET PORT WAS REMOVING A CSTD FROM THE PORT TO APPLY A FLUSH. FLUID SPRAYED FROM THE SECONDARY INLET PORT WHEN DISCONNECTED. THE REPORTED INCIDENCES FROM WERE LEAKS FROM TWO LOCATIONS. ONE WAS FROM THE SECONDARY INLET PORT (CHEMO) AND THE OTHER (DURING PRIMING SALINE) WAS FROM THE CASSETTE. ADDITIONALLY, A NURSE DISCONNECTED THE CHEMO LINE FROM THE SECONDARY INLET PORT AND PLACED A 10ML SYRINGE WITH FLUSH ON THE SECONDARY INLET PORT AND MANUALLY "WITH A STEADY PRESSURE" PUSHED A FLUSH AND THE CASSETTE LEAKED FLUID (POSSIBLY CHEMO) FROM THE LINE. THE NURSE WAS SPLASHED WITH THE FLUID (POSSIBLY CHEMO). SHE WENT HOME AND CHANGED HER CLOTHES. IT IS NOT KNOWN IF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058370 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: ADMINISTRATION SET LEAKED "BELOW" THE DRIP CHAMBER, ABOVE THE PUMP. PUMP WAS INFUSING D5W. NO PATIENT HARM. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. A SAMPLE WAS RETURNED FOR EVALUATION. THE CUSTOMER COMPLAINT WAS ABLE TO BE REPLICATED BY FILLING BAG WITH WATER AND OBSERVE SLOW LEAK FROM DRIP CHAMBER TUBING GLUE BOND. TRIED PULLING TUBING OUT OF DRIP CHAMBER TO TEST FOR WEAK BOND BUT IT HELD TOGETHER. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058368 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: SET WAS LEAKING OUT THE BACK OF THE CASSETTE. THE NURSE HAD TO TAKE OUT TUBING AND EXCHANGE. IT WAS INFUSING ON A PATIENT. NO HARM TO PATIENT. INFUSING NORMAL SALINE - NO MEDICATION. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION THE SET WAS OBSERVED TO BE ASSEMBLED CORRECTLY ACCORDING TO THE APPLICABLE DRAWING. PRIMARY LINE INFUSION DID NOT PASS SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 0.5ML/HR AND SET VOLUME OF 1.5ML. A LEAK COMING FROM INSIDE OF THE CASSETTE WAS OBSERVED AND ALARM TUBING SET PROBLEM WAS REPLICATED FOUR TIMES IN THE IVENIX INFUSION MACHINE. AIR SIDE UNDER WATER LEAK TEST WAS PERFORMED AND BUBBLES WERE OBSERVED COMING FROM UNIT. LIQUID SIDE UNDERWATER LEAK TEST WAS PERFORMED, AND BUBBLES WERE OBSERVED COMING FROM UNIT. THEREFORE, LEAK WAS CONFIRMED IN BOTH UNDER WATER LEAK TESTS. A DYE TEST WAS PERFORMED, AND IT WAS OBSERVED THAT THE LEAK WAS COMING POSSIBLY COMING FROM THE SECONDARY VALVE. THE CUSTOMER COMPLAINT IS CONFIRMED. THE LEAK IN CASSETTE COULD BE POTENTIALLY RELATED TO A MISPLACED DIAPHRAGM WHICH RESULTED IN A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058364 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: LEAKING FROM THE SECONDARY INLET PORT. THE NURSE STATES SHE WAS ABLE TO "UNSCREW" THE PORT FROM THE SET. SHE TRIED TO SCREW IT BACK ON WITH HEMOSTATS BUT IT CONTINUED TO LEAK. THE LEAKING SET WAS REPLACED BY ANOTHER SET WITHOUT INCIDENCE. THE SET WAS NOT INFUSING HAZARDOUS DRUG AND IS BEING SENT IN FOR FURTHER EVALUATION. NO PATIENT HARM. NO DELAY IN INFUSION THERAPY. THE NURSE TOOK IT UPON HERSELF TO SEE IF SHE COULD REMOVE ANY ADDITIONAL PORTS FROM SETS FROM THE SAME LOT NUMBER. SHE REPORTS SHE COULD REMOVE A SECONDARY INLET PORT WITH FORCE AIDED BY HEMOSTATS. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE SECONDARY PORT WAS SEPARATED FROM THE SET AS REPORTED BY THE CUSTOMER. SECONDARY PORT WAS MANUALLY SCREWED ON SET AND PRIMARY LINE INFUSION WAS TESTED AND DID NOT PASS SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 0.5ML/HR AND SET VOLUME OF 1.5ML. A LEAK COMING FROM INSIDE OF THE CASSETTE WAS OBSERVED AND ALARM TUBING SET PROBLEM WAS REPLICATED TWICE IN THE IVENIX INFUSION MACHINE. IT WAS NOT POSSIBLE TO PERFORM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058363 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: WE WERE ABOUT TO GIVE PATIENTS IVF INFUSION WHEN THE CHAMBER BROKE OFF FROM THE MAIN TUBING. AS YOU CAN JUST IMAGINE, WATER CAME DOWN LIKE A WATERFALL AND HAD TO MOP THE FLOORS BEFORE WE STARTED THE CASE. THE PATIENT WAS NOT HURT AND NO AIR ENTERED THE PATIENT'S BODY AS THIS HAPPENED PRIOR TO THE START OF THE CASE. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. THE DEVICE WAS RETURNED FOR EVALUATION. DRIP CHAMBER OF RETURNED ADMIN SET WAS FOUND SEPARATED FROM ADMIN SET TUBING DUE TO FAILURE OF THE GLUE BOND. NO SIGNS OF TUBING DAMAGE FROM IMPROPER USE. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058358 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: TONIGHT, WE HAD A PATIENT ON A CHEMO REGIMEN AND THE NURSE REPORTED LEAKING FROM THE CASSETTE THAT IS IN THE PRIMARY TUBING. THE DRUG HAD BEEN RUNNING FOR A SHORT TIME 2HRS WHEN IT WAS DISCOVERED AND THE NURSE REPORTS AN ESTIMATED 3 DROPS OF LEAKAGE SEEN BUT COULD HAVE BEEN MORE AS THE PATIENT WAS MOVING AROUND. WE DID STOP THE DRIP RE-MIX AND GIVE THEM A NEW BAG TO HANG AS WE COULD NOT BE SURE IF STERILITY WAS COMPROMISED. THE REGIMEN IS A COMBINATION BAG OF ETOPOSIDE/DOXORUBICIN/VINCRISTINE THAT RUNS CONTINUOUSLY OVER 24HRS FOR 5 DAYS. THE PATIENT WAS STARTED ON THE REGIMEN ON (B)(6) 2023 AND TODAY IS THE 3RD DAY OF THERAPY SO 3RD BAG TO BE HUNG. EARLIER TODAY WITH THE 2ND BAG THAT HAD BEEN RUNNING WE ALSO DID HAVE SOME LEAKING FROM THE FILTER WHICH WAS SEPARATE SITE. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLES OR PICTURES AVAILABLE FOR EVALUATION. THEREFORE, IT IS NOT POSSIBLE TO REPLICATE OR CONFIRM THE REPORTED ISSUE. THE LEAK IN CASSETTE COULD BE POTENTIALLY RELATED TO A MISPLACED DIAPHRAGM WHICH RESULTED IN A LEAK WHEN THE DIAPHRAGM WAS ACTUATED BY THE VALVE PINS IN THE PUMP. THE IN-PROCESS LEAK TESTING PROCESS FAILED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058357 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NON-CHEMO FLUID LEAKING FROM THE BACK OF THE CASSETTE. NO PATIENT HARM. DELAYED PATIENT INFUSION BY 15-20 MINUTES. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE SET WAS ASSEMBLED CORRECTLY PER THE APPLICABLE DRAWING. PRIMARY LINE INFUSION DID NOT PASS SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 0.5ML/HR AND SET VOLUME OF 1.5ML. A LEAK COMING FROM INSIDE OF THE CASSETTE WAS OBSERVED AND ALARM TUBING SET PROBLEM WAS REPLICATED TWICE IN THE IVENIX INFUSION MACHINE. AN UNDERWATER LEAK TEST WAS PERFORMED FOR VERIFYING THE LIQUID SIDE AREA OF CASSETTE AND BUBBLES WERE OBSERVED COMING FROM UNIT. AN UNDERWATER LEAK TEST WAS PERFORMED FOR VERIFYING THE AIR SIDE AREA OF THE CASSETTE AND NO BUBBLES WERE DETECTED. A DYE TEST WAS PERFORMED, AND IT WAS OBSERVED THAT THE LEAK WAS COMING FROM THE OUTLET VALVE. THE CUSTOMER COMPLAINT IS CONFIRMED. THE LEAK IN CASSETTE COULD BE POTENTIALLY RELATED TO A MISPLACED DIAPHRAGM WHICH RESULTED IN A LEAK WHEN THE DIAPHRAGM WAS ACTUATED BY THE VALVE PINS IN THE PUMP. IN ADDITION, IT COULD BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058356 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: THIS INCIDENT HAPPENED PRIOR TO BEGINNING TREATMENT WHEN THE TUBING WAS ALREADY INSERTED AND WATER WAS COMING OUT OF THE MACHINE. THE DOOR WAS OPENED TO CHECK IF IT WAS PROPERLY LOADED. THE TUBING WAS LOADED PROPERLY, BUT THE WATER WAS STILL COMING OUT OF THE PUMP. SO, THE NURSE HAD TO GET ANOTHER ADMINISTRATION SET. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. THE DEVICE WAS RETURNED FOR EVALUATION. ADMIN SET DIAPHRAGM NOT FULLY CAPTURED BY THE ADMIN SET SHELL AND ISN'T FULLY SEALING THE FLUID FLOW PATH. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058355 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: THE RN REPORTS SHE PRIMED THE TUBING WITH NS, PLACED IT IN THE PUMP AND CLOSED THE LEVER AS NORMAL. WHEN THE PUMP BEGAN TO RUN, IT SQUIRTED SALINE OUT FROM THE CASSETTE. THE NURSE REPOSITIONED THE CASSETTE THINKING MAYBE IT WAS NOT IN CORRECTLY, BUT WHEN SHE RESTARTED THE PUMP, THE SAME THING HAPPENED. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THEREFORE, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE LEAK IN CASSETTE COULD BE POTENTIALLY RELATED TO A MISPLACED DIAPHRAGM WHICH RESULTED IN A LEAK WHEN THE DIAPHRAGM WAS ACTUATED BY THE VALVE PINS IN THE PUMP. IN ADDITION, IT COULD BE RELATED TO AN INCORRECT AND POOR SEALING OF THE CASSETTE IN THE WELDER MACHINE CAUSING THE GAP AND REPORTED LEAKAGE. THE BATCH RECORDS FA23E02305 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058354 ↗
• MalfunctionSep 15, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: A SET WAS REPORTED TO LEAK FROM THE SECONDARY INLET PORT DURING PRIMING. THE CONNECTOR WAS REPORTED TO BE "VERY LOOSE AND CAME OFF." THERE WAS NO PATIENT HARM AND NO DELAY IN INFUSION. THERE WAS NO HAZARDOUS MATERIALS IN THE SET. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE SECONDARY PORT WAS SEPARATED FROM THE SET AS REPORTED BY THE CUSTOMER. IT WAS NOT POSSIBLE TO INSTALL THE UNIT INTO THE IVENIX MACHINE AS THE SECONDARY PORT WAS LOOSE AND SEPARATED FROM PORT. THE CUSTOMER COMPLAINT IS CONFIRMED. PROBABLE ROOT CAUSE OF REPORTED FAILURE COULD BE RELATED TO THE SUPPLIER MANUFACTURING PROCESS. IT IS POSSIBLE THAT THE SECONDARY PORT WAS NOT ASSEMBLED CORRECTLY CAUSING THE UNIT TO BE SEPARATED FROM CASSETTE. THE SUPPLIER OPENED A COMPLAINT TO INVESTIGATE THIS ISSUE. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058353 ↗
• MalfunctionSep 12, 2025Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: OCCLUSION DOWNSTREAM ALARM WHILE INFUSING VIA SECONDARY. 10ML SYRINGE FROM BD ATTACHED VIA SECONDARY VALVE, BUT NOT INFUSING. RN ABLE TO BACKPRIME WITH 10ML SYRINGE WITH NO ISSUE OR ALARM OCCURRING. RN CHANGED ADMINISTRATION SET AND NO UPSTREAM OCCLUSIONS OCCURRING ONCE SECONDARY BAG ATTACHED AND INFUSING. SYRINGE NOT ON RECOMMENDED MANUFACTURER LIST. DRUG USED: PRE-MED(ZOFRAN, DECADRON, BENADRYL) RN DRAWS PREMEDS UP INTO A 10ML SYRINGE. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. THE SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0013-25. THE SAMPLE WAS RETURNED WITHOUT SALINE SPIKE/DRIP CHAMBER. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 0.5ML/HR AND SET VOLUME OF 0.1ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSED SUCCESSFULLY. SECONDARY LINE INFUSION WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10 ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. ALARM "OCCLUSION UPSTREAM" WAS IN THE IVENIX LVP DISPLAY. IT WAS NOT POSSIBLE TO COMPLETE THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036961 ↗
• MalfunctionSep 11, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ONE SAMPLES OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL WERE AS CORRESPONDED TO THE SPECIFIC CODE SET-0013-25. DURING THE INSPECTION AN OVER INSERTED K -ZERO WAS IDENTIFIED IN THE SECONDARY PORT (NEEDLE-FREE ACCESS PORT). A MICROSCOPIC EXAMINATION WAS PERFORMED, AND A CRACK WAS DETECTED AT THE SECONDARY PORT DUE TO THE OVER INSERTION FOUND. CUSTOMER COMPLAINT IS CONFIRMED. THE PROBABLE ROOT CAUSE IS RELATED TO A LEAK CAUSED BY OVER INSERTION OF THE SECONDARY PORT DURING MANUFACTURING, WHICH COULD HAVE RESULTED IN A CRACK. A REPLACEMENT OF NON-ADJUSTABLE TORQUE WRENCHES WAS PERFORMED TO MITIGATE THIS ISSUE. THE CURRENT PROCESS CONTROLS DETECTION INCLUDE, 1) POST STERILIZATION SAMPLING FINAL INSPECTION, 2) THE FIRST PIECE INSPECTION WILL BE PERFORMED TO THE FIRST FINAL ASSEMBLED KIT MANUFACTURED PER SHIFT. THIS KIT WILL BE SUBMITTED TO VISUAL INSPECTION AS PER THE CLASSIFICATION OF DEFECTS INCLUDED IN THIS SPECIFICATION AND AS PER THE APPLICABLE DRAWING, 3) 100% VISUAL INSPECTION IS PERFORMED IN MANUFACTURING LINE, 4) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027324 ↗
• MalfunctionSep 3, 2025Failure to Prime; No Apparent Adverse Event; Failure to Prime; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: "WE HAVE HAD AN ISSUE WITH SEVERAL OF OUR PRIMARY TUBING KITS IN THE PAST MONTH. SEVERAL HAD CRACKS AND ONE IN WHICH WE COULD NOT FIND A CRACK ON BUT COULD NOT GET IT TO BACK PRIME. THE PRIMING ISSUE WAS FROM LOT#: FA25D01027, SET 0013-1. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: UNABLE TO PRIME AIR FROM TUBING SET. UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955732 ↗
• MalfunctionAug 21, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: MANAGER REPORTED: "MAGNESIUM RUNNING, NOTICED PUDDLE OF LIQUID UNDER THE PUMP. STOPPED MED AND NOTICED MAGNESIUM LEAKING FROM THE BOTTOM OF CASSETTE. STOPPED INFUSION THAN CHANGED TUBING." PATIENT HARM: NO. ACTIVE INFUSION STOPPED: YES. DRUG: MAGNESIUM. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862365 ↗
• MalfunctionMay 23, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: TUBING LEAK THROUGH THE DIAL. PATIENT WAS FLUSHED AFTER CHEMOTHERAPY, TREATMENT WAS COMPLETED, TUBING REMOVED FROM PUMP THEN LEAK NOTED. THERE WAS NO HARM/EXPOSURE TO PATIENT OR NURSE. NURSE WAS WEARING GLOVES. NOT ACTIVELY INFUSING. VERIFIED WITH NURSE THAT BACK PRIMING METHOD USED DURING INFUSION WAS VIA PUMP FUNCTION. TUBING NOT SAVED AS IT WAS USED TO ADMINISTER HAZARDOUS DRUG. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077650 ↗
• MalfunctionMay 13, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: TUBING LEAKING BELOW THE CASSETTE. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012919 ↗
• MalfunctionMay 13, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED : CAP MISSING FROM SECONDARY PORT. SAMPLE AVAILABLE : YES A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART) UNKNOWN IF ISSUE STOPPED AND ACTIVE INFUSION. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009735 ↗
• MalfunctionApr 21, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: RUNNING NALAXONE DRIP INTO PRIMARY TUBING. END CRACKED. PATIENT HARM/ADVERSE REACTION: NO. STOPPED ACTIVE INFUSION: YES. RESULTED IN OVER/UNDER INFUSION: NO. DRUG USED: NALAXONE. STEPS TAKEN: GOT NEW TUBING. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART). AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876304 ↗