BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60 100MG/ML

    MDR report key: 24460794 · Received February 26, 2026

    Report

    Report Number
    MW5184467
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Report Date
    February 20, 2026
    Manufacturer
    RMS MEDICAL / KORU MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THEIR FREEDOM PUMP BROKE WHILE DOING GAMUNEX INFUSION. PATIENT REPORTED THEY HAD TO WASTE 20GM FROM GAMUNEX. PUMP SERIAL NUMBER AND EXPIRATION UNKNOWN. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PRODUCT LOT AND EXPIRATION UNKNOWN. UNKNOWN IF MD IS AWARE. DOSE/AMOUNT: GAMUNEX-C 10% SDV - 20GM. GAMUNEX-C 10%SDV INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA; ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINEMIA. DID PATIENT MISS A DOSE OR HAVE AN INTERRUPTION TO THERAPY? - UNKNOWN DID ADVERSE EVENT(S) RESULT DUE TO PRODUCT ISSUE? - UNKNOWN DID PHARMACY REPLACE DEVICE? ¿ YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513372 PUMP FREEDOM 60 100MG/ML PUMP, INFUSION FRN RMS MEDICAL / KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female GAMUNEX-C 10% SDV(20GM/200ML).