BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP FREEDOM 60

    MDR report key: 12662442 · Received October 18, 2021

    Report

    Report Number
    MW5104739
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Report Date
    August 2, 2021
    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

    CALL FROM PT. PT WENT TO REPLACE HIS SECOND SET UP SYRINGE FOR INFUSION, AND SPRING SNAPPED OFF PUMP. ADVISED WITH TECH, WE ARE SENDING BRAND NEW PUMP. PT HAS BEEN USING THIS PUMP FOR SEVERAL YEARS. UNKNOWN IF DEVICE IS STILL ON HAND OR IF IT CAUSED ANY HARM TO THE PATIENT. UNKNOWN IF THE PATIENT MISSED ANY DOSES. UNKNOWN IF PATIENT HAD BACK UP DEVICE ON HAND. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550205 PUMP FREEDOM 60 PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1