BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOT LINE

    MDR report key: 419291 · Received September 27, 2002

    Report

    Report Number
    MW1026298
    Event Type
    Malfunction
    Date Received
    September 27, 2002
    Date of Event
    September 23, 2002
    Report Date
    September 27, 2002
    Manufacturer
    LEVEL 1 TECHNOLOGIES, INC.
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF OPEN HEART SURGERY, ANESTHESIA TECH NOTICED FLUID INSIDE OF LEVEL I RESERVOIR WAS PINKISH IN COLOR SUGGESTING 'MIXING' OF PT IV WITH THE FLUID FROM THE LEVEL 1 RESERVOIR. FLUID FROM L-70 TUBING SET AND HL-90 RESERVOIR TESTED POSITIVE FOR BLOOD. MFR'S QUALITY ASSURANCE DEPT WAS CONTACTED BY HOSP AND NOTIFIED OF INCIDENT. L-70 TUBING SET WILL BE SENT BACK TO MFR FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 HOT LINE FLUID WARMER BSB LEVEL 1 TECHNOLOGIES, INC. HL-90 (UNIT) *
    2 LEVEL 1 HOT LINE FLUID WARMER FPA LEVEL 1 TECHNOLOGIES, INC. L-70 (TUBING) *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR