BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART DOSE II. INFUSION CONTAINER

    MDR report key: 26351 · Received October 2, 1995

    Report

    Report Number
    MW1007155
    Event Type
    Malfunction
    Date Received
    October 2, 1995
    Date of Event
    August 18, 1995
    Report Date
    September 18, 1995
    Manufacturer
    RIVER MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    USING INFUSION CONTAINER TO DELIVER KEFLIN IV TO PT, MANY CONTAINERS AFTER ACTIVATION DID NOT INFUSE. PT "PLAYED" WITH OVER 1 HOUR MANY TIMES TO NO AVAIL. 12 DOSES MISSED AND PT REQUIRED 2 EXTRA WEEKS THERAPY. CO NOTIFIED. RPTR COULD NOT GET SYSTEM TO WORK SOMETIMES EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART DOSE II. INFUSION CONTAINER INFUSION CONTAINER MEB RIVER MEDICAL, INC. 001-002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other