BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC/DLP

    MDR report key: 175793 · Received July 6, 1998

    Report

    Report Number
    MW1014120
    Date Received
    July 6, 1998
    Date of Event
    June 30, 1998
    Report Date
    July 2, 1998
    Manufacturer
    DLP. DIVISION MEDTRONIC, INC.
    Product Code
    DWF
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PROBLEM SIMILAR TO PREVIOUS REPORT DATED 6/29/98. AIR OBSERVED BEING DRAWN INTO INFUSION PORT AND INTO ASCENDING AORTA. PRODUCT CHANGED AND SIMILAR RESULT WITH SECOND UNIT. REPLACED A THIRD TIME WITH "OTHER" LOT NUMBER. MEDTRONIC REPS ARE AWARE AND IN HOSP TODAY FOR DISCUSSIONS. FAILURE MADE DUPLICATED FOR THEM. AS PREVIOUSLY STATED, POTENTIAL FOR A VERY ADVERSE EVENT LIKELY. ATTENDANCE AT HOSP MEETING WITH MEDTRONIC QUALITY PEOPLE: HOSP PERFUSION, PRINCIPLE QA ENGINEER, MEDTRONIC QUALITY TECH, MEDTRONIC SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC/DLP DOUBLE LUMEN CARDIOPLEGIA CANNULA DWF DLP. DIVISION MEDTRONIC, INC. 30401 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR