BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 PUMP

    MDR report key: 20279770 · Received September 20, 2024

    Report

    Report Number
    MW5159878
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Report Date
    September 18, 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 (PATIENT) STATED PUMP BROKE. NO SPECIFICS PROVIDED. SERIAL NUMBER AND MAINTENANCE DUE DATE NOT PROVIDED. NO ADVERSE EVENT(S), MISSED DOSE OR INTERRUPTION TO THERAPY REPORTED DUE TO PRODUCT ISSUE. PHARMACY REPLACING PUMP. PUMP IS NOT REQUIRED TO BE RETURNED PER PHARMACIST. NO FURTHER DETAILS PROVIDED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450305 FREEDOM 60 PUMP PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ACETAMINOPHEN.| HIZENTRA.| TERIPARATIDE PEN (TEVA).