BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM PUMP

    MDR report key: 9686682 · Received February 7, 2020

    Report

    Report Number
    MW5092855
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 9, 2020
    Manufacturer
    RMS 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 FROM PATIENT¿S MOTHER REPORT FREEDOM PUMP MALFUNCTION THAT WAS NOT PUSHING THE PLUNGER OF SYRINGE AND WAS NOT ABLE TO INFUSE THE MINIMAL AMOUNT HIZENTRA LEFT. MOTHER DID NOT CALL IF PHARMACIST FOR CONSULTATION BUT STATED THAT PATIENT DID NOT HAVE NAY ADVERSE EFFECT FROM NOT INFUSING THE FULL DOSE SINCE IT WAS JUST MINIMAL AMOUNT LEFT OVER. PUMP IS BEING RETURNED FOR INSPECTION. NO TO HER INFORMATION KNOWN. REPORTED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147739 FREEDOM PUMP PUMP, INFUSION FRN RMS REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR