BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 PUMP

    MDR report key: 14787394 · Received June 22, 2022

    Report

    Report Number
    MW5110441
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    June 14, 2022
    Report Date
    June 14, 2022
    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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT INFORMED US THAT HER FREEDOM PUMP WAS NOT WORKING, SO SHE SHOOK IT, BANGED IT, AND NOW SEEMS TO BE WORKING BUT WOULD LIKE A NEW ONE. TOLD PT WE COULD SEND A RETURN BOX AND SEND HER A NEW PUMP. UNKNOWN IF PRODUCT WAS IF PUMP WAS IN USE WITH THE PATIENT, NO PATIENT INJURIES, PATIENT JUST WANTED PUMP REPLACED. NO FURTHER DETAILS WERE PROVIDED. INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090318 FREEDOM 60 PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female