BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 19995135 · Received August 14, 2024

    Report

    Report Number
    MW5158457
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 12, 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

    PT'S REPORTS THAT THEIR PUMP SNAPPED AND BROKE NEAR THE END OF HER INFUSION. NO ADVERSE EFFECTS OR INJURIES REPORTED DUE TO PRODUCT ISSUES. HIZENTRA PREFILLED SYRINGE IS STILL INTACT AND PT HAS ABOUT AN INCH OF SOLUTION REMAINING. COUNSELED TO MANUALLY PUSH ABOUT 1-2 ML EVERY MINUTE. SERIAL NUMBER AND MAINTENANCE DUE DATE NOT PROVIDED FOR 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
    2349671 PUMP FREEDOM 60 PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female HIZENTRA 20% (10GMTOTAL). | HIZENTRA 20% PFS (10GM TOTAL).