BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 23832677 · Received December 17, 2025

    Report

    Report Number
    3014732157-2025-01418
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 22, 2025
    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

    Description of Event or Problem · 0

    NO PUMP WAS RETURNED TO FRESENIUS KABI FOR EVALUATION. THE REPORTED "FAULTY PNEUMATIC SYSTEM" WAS RESOLVED BY THE MAYO DEPOT TEAM. A HISTORY REVIEW OF THE FRESENIUS KABI SERVICE RECORDS FOR REPORTED SERIAL NUMBER PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT RECORD FOUND NO SAME / SIMILAR ISSUES RELATED TO THIS COMPLAINT. A DEVICE HISTORY REVIEW OF THE REPORTED SERIAL NUMBER WAS CONDUCTED BY FRESENIUS KABI AND NO RELATED MANUFACTURING NONCONFORMANCE RECORDS WERE FOUND. THERE WERE NO OTHER INCIDENTS IN PRODUCTION OF THIS PRODUCT THAT WOULD HAVE CAUSED THE REPORTED ISSUE. ALL COMPLAINTS ARE CAPTURED IN TRACKING AND TRENDING AND REVIEWED MONTHLY TO DETERMINE IF ADDITIONAL INVESTIGATION IS REQUIRED FOR FURTHER ROOT CAUSE ANALYSIS AND ANY CORRECTIVE ACTIONS. NO ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: BIOMED REPORTED: "SERIAL NUMBER (B)(6), CONFIRMED PUMP PROBLEM ERROR, DEEP CLEAN, OPENED PUMP DEEP CLEANED, REPLACED LIP SEALS, DEEP CLEAN PINS AND MECHANISM, RAN FUNCTIONAL CHECKS, 50ML @ 250ML/HR, PUMP PLACED IN BRING UP MODE AND SENT TO THE TEST LINE, PASSED ALL STATIONS OF THE TEST LINE FRONT HOUSING , FINAL ACCEPTANCE, PROVISIONED PUMP TO 08 SERVER, SENT TO HERATHERM, PASSED HERATHERM PULLED AT 04:00 (B)(6) 2025. 24 HOUR DWELL - COMPLETE, LVP BURN-IN TEST - FAIL, VALVE 2 SLOW_CLOSURE WARNINGS OCCURRED 4 TIMES, NEEDS NEW PNEUMATICS, REPLACED FULL PNEUMATICS SYSTEM, PUMP PLACED IN BRING UP MODE AND SENT TO THE TEST LINE, PASSED ALL STATIONS OF THE TEST LINE FRONT HOUSING , FINAL ACCEPTANCE, PROVISIONED PUMP TO 08 SERVER, SENT TO HERATHERM. LOADED INTO HERATHERM @17:00 AND (B)(6) 2025, PASSED HERATHERM PULLED AT 05:00 (B)(6) 2025, 24 HOUR DWELL - COMPLETE, LVP BURN-IN TEST - PASS, ACCURACY TEST - PASS, ELECTRICAL SAFETY TEST - PASS, PROVISION PUMP TO MAYO SERVER, RETURN TO SERVICE, WORK ORDER TYPE, CORRECTIVE MAINTENANCE, ORDER DESCRIPTION, OPEN UP PUMP TO DEEP CLEAN PINS, PROBLEM CAUSE, ENVIRONMENTAL, RESOLUTION CODE, REPLACED PART, RESOLUTION DETAIL, RECEIVED AT DEPOT. QUESTION 1 WAS THERE ANY INJURY/ADVERSE REACTION (YES, PROVIDE DETAILS, NO, UNKNOWN)?:NO QUESTION 2 DID THE ISSUE STOP AN ACTIVE INFUSION (YES, NO, UNKNOWN)? NO." A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: UNDEFINED PNEUMATIC SYSTEM COMPONENT FAILURE. UNKNOWN IF ISSUE STOPPED AN ACTIVE INFUSION. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193407 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown