Ivenix, Inc. SET-0021-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00811505030108), received between Feb 19, 2025 and Mar 25, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (13 reports).

1 FDA recall record name this device's identifier, 1 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-2234-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026No Apparent Adverse Event; Air/Gas in Device

  TWO SAMPLES OF IVENIX ADMINISTRATION SET WERE RETURNED FOR EVALUATION. DURING VISUAL INSPECTION, NO DEFECTS WERE PRESENT IN THE SET. THE GOLD FOIL CORRESPONDED TO SET-0021-25. PRIMARY LINE INFUSION WAS TESTED WITH A SET RATE OF 0.5ML/HR SET VOLUME OF 0.1ML AND A SET RATE OF 1000ML/HR SET VOLUME OF 10ML , PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. AN UNDERWATER LEAK TEST WAS PERFORMED TO VERIFY THE LIQUID AND AIR SIDE AREAS OF CASSETTE, AND NO BUBBLES WERE OBSERVED COMING FROM THE UNIT. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDE 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688063 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681936 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681708 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681623 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681616 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "SHORTLY AFTER STARTING AND AT SEVERAL TIMES DURING THE INFUSION AIR IN LINE ALARMS DETECTED CAUSING THE INFUSION TO STOP UNTIL CLEARED. NO AIR WAS PRESENT DURING PRIMING BUT FORMED AFTER. NO VISIBLE AIR OR BUBBLES IN THE TUBING PROXIMAL TO THE CASSETTE. DURING PROCEDURE THIS CAUSED THE PROVIDER TO TROUBLESHOOT INCLUDING DISCONNECTING SEVERAL TIMES TO REMOVE AIR. WITH NO DE-AIRING PORT IT MUST BE DISCONNECTED FROM THE PATIENT CAUSING DISRUPTION AND CHANGES TO CARE. THIS IS AN ACUTE CHANGE FROM 2MOS AGO. THIS HAPPENED 12 TIMES TODAY, AND HAVE 1 SAMPLE AVAILABLE. PATIENT HARM: NO. SEVERAL INSTANCES WHERE AIR-IN-LINE ALARMS WERE IMPACTING THE ANESTHESIA PRACTICE. THESE AIR ISSUES HAVE CAUSED INFUSIONS TO STOP, AND ADDITIONAL INTERVENTIONS NEEDED TO KEEP THE CASE PROGRESSING, AS THE FLOW OF MEDICATION INCLUDING PROPOFOL WAS INTERRUPTED. THEY HAVE HAD THIS HAPPEN SO FAR 12 TIMES TODAY ON VARIOUS PUMPS, AND THERE ARE ESTIMATED SEVERAL DOZEN INSTANCES OF THIS RECENTLY. THEY HAVE NOT MADE ANY OTHER CHANGES TO PRACTICE, THE ONLY CHANGE IDENTIFIED IS THE NEWEST LOT NUMBERS. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: AIR IN LINE ALARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681612 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "SHORTLY AFTER STARTING AND AT SEVERAL TIMES DURING THE INFUSION AIR IN LINE ALARMS DETECTED CAUSING THE INFUSION TO STOP UNTIL CLEARED. NO AIR WAS PRESENT DURING PRIMING BUT FORMED AFTER. NO VISIBLE AIR OR BUBBLES IN THE TUBING PROXIMAL TO THE CASSETTE. DURING PROCEDURE THIS CAUSED THE PROVIDER TO TROUBLESHOOT INCLUDING DISCONNECTING SEVERAL TIMES TO REMOVE AIR. WITH NO DE-AIRING PORT IT MUST BE DISCONNECTED FROM THE PATIENT CAUSING DISRUPTION AND CHANGES TO CARE. THIS IS AN ACUTE CHANGE FROM 2MOS AGO. THIS HAPPENED 12 TIMES TODAY, AND HAVE 1 SAMPLE AVAILABLE. PATIENT HARM : NO SEVERAL INSTANCES WHERE AIR-IN-LINE ALARMS WERE IMPACTING THE ANESTHESIA PRACTICE. THESE AIR ISSUES HAVE CAUSED INFUSIONS TO STOP, AND ADDITIONAL INTERVENTIONS NEEDED TO KEEP THE CASE PROGRESSING, AS THE FLOW OF MEDICATION INCLUDING PROPOFOL WAS INTERRUPTED. THEY HAVE HAD THIS HAPPEN SO FAR 12 TIMES TODAY ON VARIOUS PUMPS, AND THERE ARE ESTIMATED SEVERAL DOZEN INSTANCES OF THIS RECENTLY. THEY HAVE NOT MADE ANY OTHER CHANGES TO PRACTICE, THE ONLY CHANGE IDENTIFIED IS THE NEWEST LOT NUMBERS. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: AIR IN LINE ALARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675784 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "SHORTLY AFTER STARTING AND AT SEVERAL TIMES DURING THE INFUSION AIR IN LINE ALARMS DETECTED CAUSING THE INFUSION TO STOP UNTIL CLEARED. NO AIR WAS PRESENT DURING PRIMING BUT FORMED AFTER. NO VISIBLE AIR OR BUBBLES IN THE TUBING PROXIMAL TO THE CASSETTE. DURING PROCEDURE THIS CAUSED THE PROVIDER TO TROUBLESHOOT INCLUDING DISCONNECTING SEVERAL TIMES TO REMOVE AIR. WITH NO DE-AIRING PORT IT MUST BE DISCONNECTED FROM THE PATIENT CAUSING DISRUPTION AND CHANGES TO CARE. THIS IS AN ACUTE CHANGE FROM 2MOS AGO. THIS HAPPENED 12 TIMES TODAY, AND HAVE 1 SAMPLE AVAILABLE. PATIENT HARM : NO SEVERAL INSTANCES WHERE AIR-IN-LINE ALARMS WERE IMPACTING THE ANESTHESIA PRACTICE. THESE AIR ISSUES HAVE CAUSED INFUSIONS TO STOP, AND ADDITIONAL INTERVENTIONS NEEDED TO KEEP THE CASE PROGRESSING, AS THE FLOW OF MEDICATION INCLUDING PROPOFOL WAS INTERRUPTED. THEY HAVE HAD THIS HAPPEN SO FAR 12 TIMES TODAY ON VARIOUS PUMPS, AND THERE ARE ESTIMATED SEVERAL DOZEN INSTANCES OF THIS RECENTLY. THEY HAVE NOT MADE ANY OTHER CHANGES TO PRACTICE, THE ONLY CHANGE IDENTIFIED IS THE NEWEST LOT NUMBERS. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: AIR IN LINE ALARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675779 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675778 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675777 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675775 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675774 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event; Air/Gas in Device

  ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0021-25. PRIMARY LINE INFUSION PASSED SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 1000ML/HR AND SET VOLUME OF 10ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. THE PRIMARY BOLUS PRIME PROCESS PASSES SUCCESSFULLY. UNDER MICROSCOPE, NO DEFECTS WERE OBSERVED AT THE ADMINISTRATION CASSETTE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT AIR IN LINE ALARM. NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT. DEFECT PROBABLY RELATED TO MEDICINE OR LIQUID SUBSTANCE USED BY THE CUSTOMER. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. THE BATCH RECORD FA25L17165 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675768 ↗
• MalfunctionOct 16, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "RN SPIKED NORMAL SALINE BAG, PULLED PAPER WRAP, PULLED TO TUBING TO STRAIGHTEN TUBING AND TUBING BECAME DISLODGED FROM DRIP CONTAINER, CAUSING FLUIDS TO PORE OUT PATIENT HARM: NO. INFUSION STOPPAGE: NO. DRUG: NORMAL SALINE. 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 23316007 ↗
• MalfunctionOct 15, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "RN WAS GOING TO SPIKE BAG WHEN TUBING BECAME COMPLETELY DISCONNECTED FROM THE DRIP CHAMBER. TUBING SENT TO SPD." PATIENT HARM: NO. INFUSION STOPPAGE: NO. 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 23304602 ↗
• MalfunctionSep 18, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  FINDINGS: NO SAMPLE OR PICTURE AVAILABLE FOR ANALYSIS. CUSTOMER COMPLAINT CANNOT BE VALID. ROOT CAUSE: THE SECONDARY PORT IS LOCKED AND NOT AVAILABLE FOR USE IN SET-0021-25, THE ONLY LINE TO BE USED IS THE PRIMARY. BASED ON ALL KNOWN INFORMATION, THERE WAS NO MALFUNCTION OR MIS-ASSEMBLY OF THE SET. THE ISSUE IS ATTRIBUTED TO CUSTOMER TRAINING/PRODUCT KNOWLEDGE. CURRENT PROCESS CONTROLS DETECTION: 100% VISUAL INSPECTION. CODE NO.: SET-0021-25. BATCH NO.: FA25E12237. EXCEPTION GENERATED: THE BATCH RECORD FA25E12237 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. QUALITY TEST RESULTS: THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087577 ↗
• MalfunctionJun 24, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: THE IVF WERE LEAKING FROM THE FLOW DIAL AREA. THE PATIENT'S BED WAS WET. WHEN YOU FLUSH THE TUBING, THE FLUIDS LEAK FROM FLOW DIAL. DRUG USED: 0.9% NS SAMPLE AVAILABLE?: YES. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). UNKNOWN IF ISSUE STOPPED AN 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 22320520 ↗
• MalfunctionJun 13, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: BLINATUMOMAB LEAKING OUT THE SIDE OF CASSETTE IN WHAT APPEARS TO BE A CRACK IN THE SEAM OF THE CASSETTE. WHEN TUBING WAS UNCLAMPPED ABOVE THE CASSETTE BLINATUMOMAB LEAKED OUT OF THE SIDE. PATIENT HARM: NO. STOPPED ACTIVE INFUSION: YES. INCIDENT TYPE: LEAK. DRUG USED DURING INFUSION: BLINATUMOMAB. ACTION TAKEN TO RESOLVE ISSUE: REPLACE TUBING. SAMPLE AVAILABLE: YES. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART). 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 22204863 ↗
• MalfunctionJun 9, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: WHILE PREPARING/MOVING FOR A ROAD TRIP - THIS TUBING DISCONNECTED FROM THE DRIP CHAMBER. NURSE HAD BEEN TRYING TO REMOVE AIR FROM TUBING WHEN IT HAPPENED. HAD TO URGENTLY GET THE NON-CONCENTRATED VERSION OF VASO TO BE ABLE TO CONTINUE THE MEDICATION. ADMINISTRATION SET SEPARATED AT WELD BETWEEN DRIP CHAMBER AND TUBING, DURING ACTIVE CONCENTRATED VASOPRESSIN INFUSION. INJURY/ADVERSE REACTION: NO, MEDICAL INTERVENTION REQUIRED: YES, STOPPED ACTIVE INFUSION: YES, OCCURRED DURING INFUSION: ON THE PRIMARY LINE, DRUG USED: VASOPRESSIN. ACTION TAKEN: HAD TO URGENTLY GET THE NON-CONCENTRATED VERSION OF VASO TO BE ABLE TO CONTINUE THE MEDICATION. ADMINISTRATION SET SEPARATED AT WELD BETWEEN DRIP CHAMBER AND TUBING, DURING ACTIVE CONCENTRATED VASOPRESSIN INFUSION. NEW TUBING WAS HUNG. 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 22169576 ↗
• MalfunctionMay 5, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED : THERE WAS A MALFUNCTION WITH IV TUBING FOR A DOBUTAMINE STRESS TEST. DOBUTAMINE STARTED AND KEPT RECEIVING AN ERROR MESSAGE THAT CASSETTE WAS NOT LOADED PROPERLY. CASSETTE RELOADED FOUR TIMES BUT STILL RECEIVED THE ERROR MESSAGE. UPON FURTHER INSPECTION FOUND THE CASSETTE WAS CRACKED AND LEAKING. PATIENT INJURY/ADVERSE REACTION : NO. STOPPED ACTIVE INFUSION : NO. OCCURRED : BEFORE USE. DRUG USED : N/A. INCIDENT TYPE : ERROR / CRACK/ LEAK. ACTION TAKEN : N/A. 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 21960291 ↗
• MalfunctionMay 1, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED : THERE WAS A MALFUNCTION WITH IV TUBING FOR A DOBUTAMINE STRESS TEST. DOBUTAMINE STARTED AND KEPT RECEIVING AN ERROR MESSAGE THAT CASSETTE WAS NOT LOADED PROPERLY. CASSETTE RELOADED FOUR TIMES BUT STILL RECEIVED THE ERROR MESSAGE. UPON FURTHER INSPECTION FOUND THE CASSETTE WAS CRACKED AND LEAKING. PATIENT INJURY/ADVERSE REACTION : NO. STOPPED ACTIVE INFUSION : NO. OCCURRED : BEFORE USE. DRUG USED : N/A. INCIDENT TYPE : ERROR / CRACK/ LEAK. ACTION TAKEN : N/A. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART). UNKNOWN IF ISSUE STOPPED AN 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 21945540 ↗
• MalfunctionApr 21, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: CASSETTE LEAKING FROM THE BOTTOM, GOLD SQUARES ARE ALSO NOT ALIGNED. PATIENT HAD DEXMEDETOMIDINE INFUSING. RN NOTICED MODERATE SIZE PUDDLE ON THE FLOOR. SOURCE OF LEAK WAS NOTED TO BE COMING FROM IV TUBING CASSETTE. PUMP DID NOT ALARM FOR ANY MALFUNCTION. NEW MEDICATION AND TUBING HUNG. OLD TUBING GIVEN TO CNS. RESULT: NEEDED TO GET DIFFERENT TUBING. - PROCESS OCCURRED: BEFORE TREATMENT. - INJURY/ADVERSE REACTION: NO. - STOP ACTIVE INFUSION: NO. - RESULTED IN UNDER/OVER-INFUSION: NO. - DRUG USED FOR INFUSION: NOT SURE. A PRELIMINARY REVIEW OF THE LOGS 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 21876709 ↗
• MalfunctionMar 14, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: NURSE REPORTED, IV TUBING LEAK AFTER ITS PUT INTO THE PUMP. CUSTOMER HAD TWO TUBINGS (UNSURE OF LOT #) THAT WERE NOT LEAKING AND WERE ABLE TO FLOW BY GRAVITY AND THEN ONCE PUT IN THE PUMP THE LIQUID WAS COMING OUT AND FLOWING DOWN THE TUBING. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) UNKNOWN IF ISSUE STOPPED AN 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 21610031 ↗
• MalfunctionMar 14, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: NURSE REPORTED, IV TUBING LEAK AFTER ITS PUT INTO THE PUMP. CUSTOMER HAD TWO TUBINGS (UNSURE OF LOT #) THAT WERE NOT LEAKING AND WERE ABLE TO FLOW BY GRAVITY AND THEN ONCE PUT IN THE PUMP THE LIQUID WAS COMING OUT AND FLOWING DOWN THE TUBING. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). UNKNOWN IF ISSUE STOPPED AN 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 21610025 ↗
• MalfunctionFeb 26, 2025Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event

  NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IT IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE POTENTIAL ROOT CAUSES OF THE LEAK FROM THE CASSETTE COULD BE RELATED TO 1) MISPLACED DIAPHRAGM WHICH RESULTED IN A LEAK WHEN THE DIAPHRAGM WAS ACTUATED BY THE VALVE PINS IN THE PUMP, 2) AN INCORRECT AND POOR SEALING OF THE CASSETTE IN THE WELDER MACHINE CAUSING THE REPORTED LEAKAGE, 3) OVER-INSERTION OF THE SECONDARY PORT WHICH CAUSED A CRACK AT THE CASSETTE, 4) CASSETTE SEAL NOT ASSEMBLED CORRECTLY CAUSING A LEAK IN THE FLOW DIAL. THE CURRENT PROCESS CONTROLS DETECTION INCLUDE 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS, 3) 100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471760 ↗