BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4000-0106-01

    MDR report key: 23638768 · Received November 24, 2025

    Report

    Report Number
    3012307300-2025-12842
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 24, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE EVENT HISTORY LOG (EHL) WAS REVIEWED THERE WAS A MOTOR RATE ERROR. THE DEVICE WAS VISUALLY INSPECTED. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE DEPLETED BATTERY PACK. AS A RESULT, THE BATTERY PACK WAS REPLACED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE DEVICE PASSED ALL FUNCTIONAL TESTING AFTER REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP EXHIBITED A PUMP MOTOR DRIVE PHASE B POST. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A MOTOR RATE ERROR. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314566 4000-0106-01 PUMP, INFUSION FRN ICU MEDICAL, INC. 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown