BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEBORAH HEART & LUNG 6

    MDR report key: 612209 · Received June 7, 2005

    Report

    Report Number
    1718850-2005-00019
    Event Type
    Other
    Date Received
    June 7, 2005
    Date of Event
    May 12, 2005
    Report Date
    June 7, 2005
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE CRYSTALLOID TUBING IN THE RACEWAY SPLIT. THE SET WAS CHANGED OUT IN ORDER TO COMPLETE THE CASE. BLOOD LOSS WAS 25 CC. NO INTERVENTION WAS REQUIRED TO COMPENSATE FOR THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEBORAH HEART & LUNG 6 CUSTOM PERFUSION PACK DWE COBE CARDIOVASCULAR, INC. NA 050900004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other