BEUDAMED
    FDA Adverse Event Summary report: N

    HEART VALVE ALLOGRAFT

    MDR report key: 29160 · Received December 28, 1995

    Report

    Report Number
    MW1008026
    Date Received
    December 28, 1995
    Date of Event
    December 1, 1992
    Report Date
    December 28, 1995
    Manufacturer
    AMERICAN RED CROSS
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER RPTR, APPARENTLY, THE DONOR BLOOD AND TRANSPORT SOLUTION TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA, BUT AFTER EXPOSURE TO THE ANTIBIOTIC COCKTAIL, THE COCKTAIL AND CO-PROCESSED TISSUE CULTURED NEGATIVE, SO THE PROCESSOR FELT THAT THE TISSUE WAS STERILE AND RELEASABLE. THERE WERE TWO RECIPIENTS WHO RECEIVED VALVES FROM THIS DONOR. BOTH, RPTR BELIEVES WERE CHILDREN. ONE APPARENTLY PRESENTED WITH HEART TROUBLE AND PNEUMONIA (ORGANISM UNKNOWN). THIS PT DEVELOPED AN INFECTION WITH THE PSEUDOMONAS ORGANISM WITHIN A COUPLE DAYS OF THE 12/29/92 IMPLANT. (BLOOD AND WOUND CULTURED POSITIVE). SURGICAL DEBRIDEMENT WAS DONE, THEN A BLEEDER DEVELOPED SECONDARY TO THE DEBRIDEMENT, SO THE PT UNDERWENT AN OPERATION TO CLOSE THE BLEEDER. AFTER A LONG COURSE, AND AFTER TRANSFER TO ANOTHER HOSP, THE PT WAS DISCHARGED IN 2/93, AND RETURNED A WEEK LATER WITH THE SAME INFECTION. THE INFECTION APPARENTLY FINALLY RESOLVED AND THE PT IS ALIVE; 2/95 WAS THE LAST KNOWN ASSESSMENT. (SEE 1008027.) DATE IMPLANTED 12/29/92.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART VALVE ALLOGRAFT Implant HEART VALVE ALLOGRAFT MIE AMERICAN RED CROSS

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO