BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC

    MDR report key: 22702224 · Received August 4, 2025

    Report

    Report Number
    3014732157-2025-00839
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 25, 2025
    Report Date
    September 24, 2025
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030030
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "PT HAD PLATELETS ORDERED, RN WENT TO HANG PLATELETS. UPON PROGRAMMING PUMP AND GOING TO BACK PRIME SALINE INTO SECONDARY BLOOD TUBING IV PUMP BEEPED AND ALERTED PRIMARY OCCLUSION AND WOULDN'T BACK PRIME INTO BLOOD TUBING. ALL CLAMPS WERE OPEN. IV PUMP WAS TURNED OFF AND RESTARTED. ISSUE CONTINUED. IV PUMP WAS CHANGED, ISSUE CONTINUED. NEW BLOOD TUBING WAS PRIMED AND PROGRAMED INTO PUMP; ISSUE NO LONGER PERSISTED." INJURY/ADVERSE REACTION: NO. INFUSION STOPPAGE: NO. . A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: UNABLE TO PRIME AIR FROM TUBING SET. AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    FINDINGS: NO SAMPLE OR PICTURE AVAILABLE FOR ANALYSIS. NOTE: WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED. POTENTIAL ROOT CAUSES (PRIMING ERROR- IMPOSSIBLE TO BACKPRIME) COULD BE RELATED TO: EXCESS GLUE IN SECONDARY PORT CAUSING AND OBSTRUCTION. POTENTIAL ROOT CAUSES (OCCLUSION ALARM) COULD BE RELATED TO: KINKS LOCATED SOMEWHERE IN THE ADMIN SET. BLOCKAGE / OCCLUSIONS AT CONNECTIONS OR PORTS. SLIDE CLAMPS BEING ACTUATED ON THE TUBING. CURRENT PROCESS CONTROLS DETECTION (PRIMING ERROR- IMPOSSIBLE TO BACKPRIME): 100% LEAK AND OCCLUSION TEST ARE PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE. QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. 100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS. CURRENT PROCESS CONTROLS DETECTION (OCCLUSION ALARM): 100% LEAK AND OCCLUSION TEST ARE PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE. QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS. 100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS. CODE NO.: SET-0014-20. BATCH NO.: FA24K0523. EXCEPTION GENERATED: THE BATCH RECORD FA24K0523 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231148 IVENIX, INC LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL FPA FRESENIUS KABI USA LLC SET-0014-1 FA24K0523 00811505030030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown