BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC/DLP

    MDR report key: 175720 · Received July 2, 1998

    Report

    Report Number
    MW1014115
    Event Type
    Malfunction
    Date Received
    July 2, 1998
    Date of Event
    June 19, 1998
    Report Date
    June 29, 1998
    Manufacturer
    DLP, DIV. MEDTRONIC, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFUSION PORT ON THIS PRODUCT WAS "LOOSE" ON THE FEMALE LUER CONNECTOR. WHEN TUBING IS ADVANCED OVER THE LUER CONNECTOR, GROOVES IN CONNECTER PERMIT INTRODUCTION INTO ASCENDING AORTA OF AIR. THIS HAS THE POTENTIAL FOR A VERY ADVERSE EVENT. FACILITY HAS NOW HAD PERHAPS 6 OR MORE OF THIS PRODUCT WITH THIS PROBLEM DESCRIBED. THIS PROBLEM HAS BEEN REPORTED TO A QUALITY TECH OF MEDTRONIC/DLP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR