BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60

    MDR report key: 20112402 · Received August 29, 2024

    Report

    Report Number
    MW5159135
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 23, 2024
    Report Date
    August 23, 2024
    Manufacturer
    KORU MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNSOLICITED COMMUNICATION. PT'S MOTHER REPORTED THAT PT. MISSED INFUSION TODAY- DUE TO PUMP MALFUNCTION. ONE DOSE (CUTAQUIG 5GM) NEEDS TO BE REPLACED DUE TO FREEDOM 60 SERIAL NUMBER: (B)(6)) MALFUNCTION. MAINTENANCE DUE DATE IS UNKNOWN. PT'S MOTHER REPORTED THAT SHE STARTED INFUSING DOSE ABOUT 2 HOURS AGO AND NOTHING HAS BEEN INFUSED YET. THE DIAL ON FREEDOM 60 PUMP KEEPS WINDING AND NO CLICKING NOISE. PUMP AVAILABLE FOR RETURN. UNKNOWN IF PATIENT EXPERIENCE AN ADVERSE EVENT AS A RESULT. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. INDICATIONS: COMMON VARIABLE IMMUNODEFICIENCY WITH PREDOMINANT ABNORMALITIES OF B-CELL NUMBERS AND FUNCTION; OTHER IMMUNODEFICIENCIES WITH PREDOMINANTLY ANTIBODY DEFECTS. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055208 FREEDOM 60 PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC. F10050

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CUTAQUIG 5DV| LUPRON PED 6-MONTI-DEPOT