BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GISH VISION SYSTEM

    MDR report key: 512813 · Received February 12, 2004

    Report

    Report Number
    MW1031171
    Event Type
    Injury
    Date Received
    February 12, 2004
    Date of Event
    January 30, 2004
    Report Date
    February 12, 2004
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ON CPB DURING PERFORMANCE OF CABG X5/MV ANNULOPLASTY, PT DEVELOPED HYPOTENSION AS A RESULT OF "SPLATION" OF CPB TUBING. PERFUSIONIST IMMEDIATELY SPLICED A NEW SECTION OF TUBING INTO RACEWAY. PT SUCCESSFULLY REPLACED ON BYPASS. CORE TEMP 34.5/NO CROSS CLAMP IN USE. AS PER SAME, APPROXIMATELY LESS THAN 3' REPORTED TOTAL INCIDENT TIME. MANUFACTURERS OF BOTH TUBING AND BYPASS MACHINE CONTACTED-ISSUE OF "SPLATION" MAYBE RELATED TO SPEED OF TUBING IN RACEWAY WHILE WAITING TO GO ON CPB. ALL PERFUSIONISTS RE-EDUCATED RE: MAINTENANCE/STANDARDIZED RACEWAY SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GISH VISION SYSTEM PVC TUBING FOR CPB ARTERIAL ROLLER PUMP TUBING DWF GISH BIOMEDICAL, INC. A14034-04 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R