BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 25231863 · Received May 20, 2026

    Report

    Report Number
    3014732157-2026-02226
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 28, 2026
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FRN
    UDI-DI
    00811505030320
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: DEEP CLEANED MECHANISMS, LOADED CARTRIDGE, UNIT ATTEMPTED TO ROTATE DIAL AND FAILED. SEND TO DEPOT FOR REPAIR. RECEIVED AT DEPOT. CONFIRMED PUMP PROBLEM. STICKY PINS DUE TO SOIL BUILD UP. DEEP CLEAN SCREEN. CLEAN PINS AND MECHANISM. OPENED PUMP DEEP CLEANED. REPLACED LIP SEALS. RE HOMED AND GREASED RESISTOR MOTOR. PUMP PLACED IN BRING UP MODE AND SENT TO THE TEST LINE. PASS ALL STATIONS OF THE TEST LINE FRONT HOUSING" FINAL ACCEPTANCE. PROVISIONED PUMP TO 08 SERVER SENT TO HERATHERM. LOADED INTO HERATHERM @ 18.30 AND 04/12/2026. PASSED HERATHERM PULLED @ 06:30 04/13/2026. 24 HOUR DWELL - COMPLETE. LVP BURN-IN TEST" VALVE 2 FAIL 788 TIMES. NEEDS NEW PNEUMATICS SENT BACK TO REPAIR LINE. REPLACED FULL PNEUMATICS SYSTEM. PUMP PLACED IN BRING UP MODE AND SENT TO THE TEST LINE. PASS ALL STATIONS OF THE TEST LINE FRONT HOUSING" FINAL ACCEPTANCE. PROVISIONED PUMP TO 08 SERVER SENT TO HERATHERM. LOADED INTO HERATHERM @ 16:00 AND 05/01/2026. PASSED HERATHERM PULLED @ 04:00 05/02/2026. 24 HOUR DWELL - COMPLETE. LVP BURN-IN TEST" PASS. ACCURACY TEST - PASS. ELECTRICAL SAFETY TEST - PASS. PROVISION PUMP TO (B)(6). RETURN TO SERVICE. PROVISIONED PUMP. SOFTWARE UPDATE COMPLETE. THE DEVICE WAS REPAIRED BY THE CUSTOMER; FRESENIUS KABI IS COMMUNICATING THE INVESTIGATION AND REPAIR RESULTS HERE. FRESENIUS KABI WILL NOT BE RECEIVING THE DEVICE OR THE PARTS BACK FOR INVESTIGATION.' A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: MECHANICAL HARDWARE FAILURE (AV STICKY VALVE). AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88547 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA, LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1