BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART DOSE II 100 ML & 100 M/HR IV SET

    MDR report key: 21430 · Received April 24, 1995

    Report

    Report Number
    MW1005706
    Event Type
    Malfunction
    Date Received
    April 24, 1995
    Date of Event
    March 29, 1995
    Report Date
    March 30, 1995
    Manufacturer
    RIVER MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT, OUR MFG ENGINEERING DEPT EXAMINED THE UNITS AND CONFIRMED THAT THE FAILURES AND CAUSES FOUND IN BOTH UNITS NOTED BY THE RPTR DID NOT SUGGEST THAT THE DEVICES WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR "SERIOUS INJURY" IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART DOSE II 100 ML & 100 M/HR IV SET CO2 POWERED INFUSION DEVICE MEB RIVER MEDICAL, INC. 4100142, 4090102

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other