BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY 6400

    MDR report key: 521590 · Received March 23, 2004

    Report

    Report Number
    MW1031723
    Event Type
    Injury
    Date Received
    March 23, 2004
    Date of Event
    March 20, 2004
    Report Date
    March 22, 2004
    Manufacturer
    SMITH (SIMS DELTEC)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT ON CONSTANT INFUSION OF FLOLAN USING LEGACY PUMP. WHEN PT HOOKED UP NEW CASSETTE THEY FORGOT TO REMOVE RED CAP FROM LINE. SINCE THE RED CAP IS UNIVERSAL IT FITS ON FEMALE RECEIVER BUT BLOCKS THE FLOW. PUMP DIDN'T ALARM HIGH PRESSURE SO PT DIDN'T GET ANY MEDICATION ALL DAY LONG. CHANGED PUMPS, SECOND PUMP ALARMED HI PRESSURE. WENT TO HOSPITAL WHERE THE RED CAP WAS DISCOVERED TO BE BLOCKING LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGACY 6400 AMBULATORY PUMP FRN SMITH (SIMS DELTEC) 6400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization