BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERFUSION PACK, PUMP & TABLE W/VANGUARD; ST. JOSEPH HOSPITAL

    MDR report key: 606865 · Received May 24, 2005

    Report

    Report Number
    1718850-2005-00014
    Event Type
    Other
    Date Received
    May 24, 2005
    Date of Event
    April 22, 2005
    Report Date
    May 24, 2005
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CARDIOPLEGIA TUBING SPLIT IN THE RECEWAY. CARDIOPLEGIA ADMINISTRATION WAS STOPPED TO CHANGE THE TUBING SET OUT. THE BLOOD LOSS WAS MINIMAL AND NO INTERVENTION WAS REQUIRED TO COMPENSATE FOR THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION PACK, PUMP & TABLE W/VANGUARD; ST. JOSEPH HOSPITAL CUSTOM PERFUSION DWE COBE CARDIOVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other