BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60-PUMP

    MDR report key: 9932867 · Received April 6, 2020

    Report

    Report Number
    MW5094042
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    March 23, 2020
    Report Date
    March 23, 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 FREEDOM PUMP STOPPED IN THE MIDDLE OF THE INFUSION. PATIENT WAS ABLE TO FINISH THE INFUSION. UNK IF DEVICE IS STILL ON HAND IN CASE A RETURN IS REQUESTED. NEW PUMP TO SHIP ON 03/26/2020. NO ADDITIONAL INFORMATION. UNKNOWN IF PT EXPERIENCED ANY ADVERSE EVENTS. SERIAL NUMBER UNKNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395335 FREEDOM 60-PUMP PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR