BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIMMER-HALL STERNUM SAW

    MDR report key: 216810 · Received March 30, 1999

    Report

    Report Number
    216810
    Event Type
    Death
    Date Received
    March 30, 1999
    Date of Event
    December 31, 1998
    Report Date
    March 29, 1999
    Manufacturer
    ZIMMER HALL SURGICAL
    Product Code
    KFK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT VENTRICULAR LACERATION OCCURRED DURING REPEAT STERNOTOMY IN A PT WITH A HISTORY OF "MUSTARD" PROCEDURE FOR TRANSPOSITION OF THE GREAT ARTERIES AND HODGKIN'S LYMPHOMA. SHE HAD ACUTE CARDIAC FAILURE REQUIRING OPEN CHEST MASSAGE, FAILURE TO WEAN FROM CARDIOPULMONARY BYPASS AND CONVERSION TO EXTRACORPOREAL MEMBRANE OXYGENATION. PT EXPIRED 1/27/99. (A "RE-DO" STERNAL SAW WAS AVAILABE, BUT NOT USED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER-HALL STERNUM SAW * KFK ZIMMER HALL SURGICAL 5059-05 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death THE HOSP USES THREE STERNAL SAWS, HOWEVER THE| INVOLVED SAW WAS NOT RECORDED.