BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 24433527 · Received February 24, 2026

    Report

    Report Number
    MW5184363
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Report Date
    February 19, 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

    PT REPORTED WHEN THEY WOUND BACK THE PUMP THE SPRING BROKE OUT OF IT. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. 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: GAMMAGARD LIQ SOLN - 12GM. GAMMAGARD LIQ SOLN INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED; SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [IGG] SUBCLASSES. DID PT 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; IS DEVICE ASSOCIATED WITH EVENT AVAILABLE FOR RETURN? - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499725 PUMP FREEDOM 60 PUMP, INFUSION FRN RMS MEDICAL /KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female GAMMAGARD LIQ SOLN.