BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE DRAPE

    MDR report key: 488915 · Received October 9, 2003

    Report

    Report Number
    488915
    Event Type
    Malfunction
    Date Received
    October 9, 2003
    Date of Event
    December 1, 2002
    Report Date
    December 1, 2002
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE SURGICAL PROCEDURE (KIDNEY TRANSPLANT) DURING ROOM CLEAN-UP, FLUID/MOISTURE WAS FOUND IN THE BOTTOM RESERVOIR OF THE "HUSH-SLUSH" MACHINE. THIS INDICATES POTENTIAL CONTAMINATION FROM A DRAPE PERFORATION USED FOR THE PURPOSE OF KIDNEY TRANSPLANTATION. THE DEVICE WAS DISCARDED BY THE O.R. (OPERATING ROOM) STAFF IN THE ROOM. THERE HAVEN'T BEEN ANY PROBLEMS WITH THIS DRAPE PRIOR TO THE RECENT EVENTS. THE PT WAS PLACED ON ANTIBIOTIC THERAPY POST-OPEATIVELY BY THE PHYSICIAN. THE PT DID WELL INITIALLY; HOWEVER, IN 2003 THE PT WAS ADMITTED TO THE HOSP WITH FEVER, CHILLS AND NAUSEA. FACILITY WILL CONTINUE TO MONITOR THIS PT. IT IS NOT KNOWN IF THE MFR HAS BEEN NOTIFIED OF THIS SITUATION. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE DRAPE SOLUTION DRAPE KKX O.R. SOLUTIONS, INC. H3204102D *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other