BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 24821408 · Received April 8, 2026

    Report

    Report Number
    3014732157-2026-00384
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 16, 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

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: SERIAL NUMBER (B)(6), DEEP CLEANED MECHANISMS, FUNCTIONAL CHECK COMPLETE, UNIT ALERTED SERVICE NEEDED DURING INFUSION. SEND TO DEPOT FOR REPAIR. PULLED LOGS. PRELIMINARY INVESTIGATION: PNEUMATIC VALVE ACTUATION FAILURE (VALVE 1) PUMP WILL BE REPAIRED BY THE MAYO SERVICE TEAM. NO PUMP RETURN. COULD THE ISSUE STOP AN ACTIVE INFUSION: YES. DID THE ISSUE STOP AND ACTIVE INFUSION: YES. COULD THE ISSUE RESULT IN AN OVER/UNDER INFUSION: YES. DID THE ISSUE RESULT IN AN OVER/UNDER INFUSION: NO. COULD THIS ISSUE PREVENT AN INFUSION START UP: YES. 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 @ 16:00 AND (B)(6) 2026. AFTER THIS, THE PUMP EXPERIENCED A MINOR PUMP ALARM DURING FINAL TESTING, WHICH DOES NOT INTERRUPT INFUSION OPERATIONS. REPORTING AS A CONSERVATIVE MEASURE DUE TO THE ISSUE REPORTED (PNEUMATIC VALVE ACTUATION FAILURE (VALVE 1)). NO ADVERSE EFFECTS REPORTED. THE DEVICE WAS REPAIRED BY THE CUSTOMER; FRESENIUS KABI IS COMMUNICATING THE INVESTIGATION AND REPAIR RESULTS HERE. FRESENIUS KABI WILL RECEIVE THE DEVICE BACK FOR INVESTIGATION/REPAIR ON THE MINOR PUMP ALARM, AS THE CUSTOMER HAD ALREADY PERFORMED REPAIRS FOR THE PNEUMATIC VALVE ISSUE.

    Description of Event or Problem · 0

    NO PUMP WAS RETURNED TO FRESENIUS KABI FOR EVALUATION. THE REPORTED "PNEUMATIC VALVE ACTUATION FAILURE (VALVE 1)" 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458642 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown