BEUDAMED
    FDA Adverse Event Other Summary report: N

    IVAC SPEC-SETS ADMINISTRATION SETS

    MDR report key: 331484 · Received April 20, 2001

    Report

    Report Number
    MW4002992
    Event Type
    Other
    Date Received
    April 20, 2001
    Date of Event
    March 9, 2001
    Report Date
    April 16, 2001
    Manufacturer
    IVAC CORP
    Product Code
    BRZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTER WAS PRIMING THE IV TUBING FOR BLOOD AND AS THEY LOOSENED THE CLAMP FOR THE BLOOD PORT, BLOOD BEGAN TO SPILL FROM THE TUBING. REPORTER RUSHED THE BLOOD AND IV POLE TO THE SINK TO TRY AND EVALUATE THE SOURCE OF THE LEAK AND HAD A TECH ON FLOOR COME HELP EVALUATE WHERE THE LEAK WAS FROM. TECH IDENTIFIED A LEAK COMING FROM THE CLEAR PLASTIC TUBING JUST BELOW THE CLAMP FOR THE BLOOD PORT. THEN HAD TO SEND FOR ANOTHER UNIT OF BLOOD. THERE WAS A BLOODBOURNE EXPOSURE TO HEALTHCARE WORKER. THE EXPOSURE IS BEING FOLLOWED BY INFECTION CONTROL. DEVICE WAS TWO YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18487 IVAC SPEC-SETS ADMINISTRATION SETS IV TUBING, BLOOD SET W/1 VLV BRZ IVAC CORP * 906534

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other