BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 19683895 · Received July 3, 2024

    Report

    Report Number
    MW5157043
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    June 28, 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

    INDICATION: COMMON VARIABLE IMMUNODEFICIENCY WITH PREDOMINANT ABNORMALITIES OF B-CELL NUMBERS AND FUNCTION. UNSOLICITED. PT REPORTS FREEDOM 60 PUMP DIAL MALFUNCTION. PUMP DOES "NOT WIND BACK". SERIAL NUMBER AND MAINTENANCE DUE DATE OF PUMP ASSOCIATED WITH EVENT UNKNOWN. UNKNOWN IF PT MISSED DOSE. NO ADVERSE EVENT(S) REPORTED DUE TO PRODUCT ISSUE. PHARMACY TO REPLACE PUMP. UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFO. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152401 PUMP FREEDOM 60 PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male "XELIA VZ XR".| HIZENTRA.