BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DLP SINGLE STAGE VENOUS CANNULA

    MDR report key: 2243442 · Received August 19, 2011

    Report

    Report Number
    2184009-2011-00044
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K842375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RESULTS = ANALYSIS CONFIRMED BROKEN CANNULA. CONCLUSION = CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LAB, VISUAL INSPECTION REVEALED A BREAK IN THE CANNULA BODY, APPROX 7 INCHES FROM DISTAL TIP. THE BREAK WAS APPROX 350 DEGREES AROUND THE CIRCUMFERENCE OF THE CANNULA BODY. THERE WERE NO SIGNS OF DENTS OR DAMAGE IN THE CANNULA BODY. CONCLUSION: ANALYSIS COULD NOT DETERMINE THE ROOT CAUSE OF THE BREAK IN THE CANNULA. AN IN DEPTH INVESTIGATION TO DETERMINE ROOT CAUSE IS UNDERGOING. UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO INDICATING THAT 45 MINUTES INTO A MITRAL VALVE/CORONARY ARTERY BYPASS SURGERY, THE VENOUS LINE FILLED WITH AIR AND THIS VENOUS CANNULA WAS FOUND TO BE ALMOST BROKEN IN HALF. THE BREAK WAS IN THE WIRE REINFORCED AREA, APPEARING VERY CLEAN AND STRAIGHT AS IF CUT. THE SURGEON TAPED THE BROKEN PART TOGETHER, WHICH EFFECTIVELY SECURED THE CANNULA FOR THE REMAINDER OF THE CASE. THERE WERE NO ADVERSE PT EFFECTS AND THE POST OPERATIVE COURSE WAS UNEVENTFUL. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP SINGLE STAGE VENOUS CANNULA DWF MEDTRONIC PERFUSION SYSTEMS 69328 2011041588

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other