BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 PURNP

    MDR report key: 14712032 · Received June 15, 2022

    Report

    Report Number
    MW5110345
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 13, 2022
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PUMP MALFUNCTION TELEMED PAGE C/B TO PT, PT STS HER FREEDOM60 PUMP IS MALFUNCTIONING AND SHE HAS ALREADY DRAWN UP HER TWO VIALS. TROUBLESHOT PUMP W/O RESULT. PAGE FORWARDED TO RX ON CALL FOR PUMP REPLACEMENT AND DIRECTION FOR MEDICATION STORAGE. PT DECLINED FURTHER NEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441607 FREEDOM 60 PURNP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female