BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOLIFE, INC.

    MDR report key: 557400 · Received November 29, 2004

    Report

    Report Number
    557400
    Event Type
    Injury
    Date Received
    November 29, 2004
    Date of Event
    November 18, 2004
    Report Date
    November 23, 2004
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    2004 OPERATION PERFORMED: REDO RIGHT VENTRICLE TO PULMONARY ARTERY CONDUIT, UTILIZING A 23 MM PORCINE STENTLESS VALVE, SUTURE CLOSURE OF PATENT FORAMEN OVALE, PULMONARY ALLOGRAFT PATCH ANGIOPLASTY OF RIGHT PULMONARY ARTERY. ROUTINE SMALL SAMPLE SENT TO MICROBIOLOGY LABORATORY FOR TESTING AT TIME OF SURGERY. IN THE NEXT DAY MICROBIOLOGY TESTS RESULTS: 4 + STAPHYLOCOCCUS AUREUS METHICILLIN RESISTANT MEC A GENE DETECTED. PICU PHYSICIANS AND HOSPITAL EPIDEMIOLOGY COORDINATOR WERE NOTIFIED BY MICROBIOLOGY. THE DECISION WAS MADE TO TREAT PT FOR MRSA ENDOCARDITIS. THAT SAME DAY CRYOLIFE WAS NOTIFIED BY HOSPITAL EPIDEMIOLOGY. 3 DAYS LATER CRYOLIFE CALLED AND IS INVESTIGATING THE DONOR OF TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE, INC. PULMONARY ARTERY CONDUIT MWH CRYOLIFE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R