BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE FREEDOM 60

    MDR report key: 25104049 · Received May 6, 2026

    Report

    Report Number
    MW5187822
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Report Date
    May 4, 2026
    Manufacturer
    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-PATIENT WHO STATED THAT HIS FREEDOM PUMP HAS FAILED. HE WAS HAVING ISSUES WITH THE SECOND PT-PATIENTS BUT MANAGED TO INFUSE AND ON HIS 3RD PFS- PRE-FILLED SYRINGE, IT STOPPED WORKING WITH ABOUT ~20ML-MILLILITER REMAINING. HE STATED THERE WAS A CRUNCHING NOISE COMING FROM THE PUMP. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT. PHARMACY IS REPLACING DEVICE. UNKNOWN IF PUMP IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION, DETAILS OR DATES PROVIDED. SERIAL NUMBER: (B)(6) HIZENTRA INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489865 THE FREEDOM 60 PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male HIZENTRA 20% PFS (10GM TOTAL).