BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 - PUMP

    MDR report key: 10167700 · Received June 17, 2020

    Report

    Report Number
    MW5095064
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Report Date
    June 8, 2020
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL, PATIENT REPORTED THAT HER PUMP IS NO LONGER WORKING. MEDICATION WAS DRAWN UP, AND DID NOT WANT TO MANUALLY INFUSE. PATIENT STATED THAT SHE HAD EXTRA MEDICATION ON HAND AND WOULD DOSE IN A DIFFERENT MANNER THAN PRESCRIBED. THE PHARMACIST ADVISED THE PATIENT THAT HER INTENDED DOSING WAS OUTSIDE OF GUIDELINES AND THAT THE PRESCRIBER WOULD NEED TO BE CONTACTED FOR AN UPDATED ORDER. NO FURTHER INFORMATION PROVIDED NO ADVERSE EVENT WAS REPORTED. UNKNOWN IF DEFECTIVE DEVICE ON HAND FOR RETURN FOR INVESTIGATION. NEW DEVICE BEING SENT. INDICATION - OTHER OVERLAP SYNDROMES, CHRONIC MIGRAINE WITHOUT AURA, INTRACTABLE, WITHOUT STATUS MIGRAINOSUS PSORIASIS IS VULGARIS. DOSING INFORMATION: INFUSE 10MG PER (50 ML) SUBCUTANEOUSLY DAILY FOR DAYS 1-13. TAKE 5 GRAMS ON DAY 14 FOR A TOTAL OF 135 GRAMS OVER 14 DAYS. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629903 FREEDOM 60 - PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1