BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL VISION ARTERIALPACK

    MDR report key: 514127 · Received February 19, 2004

    Report

    Report Number
    MW1031304
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    February 13, 2004
    Report Date
    February 19, 2004
    Manufacturer
    GISH BIOMEDICAL INC.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ON CPB FOR MORE THAN 4 HRS WITH TEMP OF 33.4C, SPALLATION OF ARTERIAL RACEWAY TUBING OCCURRED. PUMP OFF FOR APPROX 3-4 MINS. NEW TUBING INSERTED; POSTOPERATIVELY, PT. NEUROLOGICALLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL VISION ARTERIALPACK CPB TUBING DWE GISH BIOMEDICAL INC. * 363313

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR