BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 MM HEMASHIELD ARTERIAL CANNULA

    MDR report key: 938477 · Received November 3, 2007

    Report

    Report Number
    1220648-2007-00007
    Event Type
    Malfunction
    Date Received
    November 3, 2007
    Date of Event
    October 5, 2007
    Report Date
    November 2, 2007
    Manufacturer
    ABIOMED, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P900023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH CANNULAS WERE EXPLANTED AND DISCARDED BY THE HOSPITAL IN 2007. RETAIN CANNULA SAMPLES WERE TESTED. RESULTS AND CONCLUSIONS WILL BE SUMMARIZED IN FOLLOW-UP/FINAL REPORT. INFORMATION ON SECOND (RIGHT) CANNULA. LOT NUMBER: 1013375. CATALOG NUMBER: 0506-0110-HAR. DEVICE MANUFACTURER DATE: 7/2007. EXPIRATION DATE: 8/31/2009.

    Description of Event or Problem · 1

    BI-VAD IMPLANT AB5000 VENTRICLE. BLEEDING WAS OBSERVED THROUGHOUT BOTH CANNULA/GRAFT WHEN SUPPORT WAS INITIATED. THE PATIENT WAS SEPTIC AND HAD ELEVATED ANTI-COAGULANTS; BLEEDING WAS RESOLVED WHEN THE PHYSICIAN WAS ABLE TO GET ANTI-COAGULANTS TO NORMAL LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 MM HEMASHIELD ARTERIAL CANNULA CARDIAC ASSIST DSQ ABIOMED, INC. 1012582

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention