BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR SOLUTIONS

    MDR report key: 1372268 · Received April 22, 2009

    Report

    Report Number
    1372268
    Event Type
    Malfunction
    Date Received
    April 22, 2009
    Date of Event
    April 13, 2009
    Report Date
    April 21, 2009
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    STAFF DESCRIPTION: "RN NOTED LACTATED RINGER'S HAD LEAKED INTO THE SOLUTION WARMER THROUGH THE STERILE DRAPE. UPON INSPECTION, I NOTED AND CIRCLED A 5MM TEAR IN THE DRAPE. THE TEAR WAS NOT UNIFORM THROUGHOUT, APPEARED MORE LIKE A "MELTED TEAR." THE ATTENDING SURGEON, DR. WAS MADE AWARE. THE DRAPE WAS PLACED INTO A BIOHAZARD BAG, ALONG WITH THE PACKAGE INSERT. THE SOLUTION WARMER WAS SENT TO BIOMED FOR A MAINTENANCE CHECK. CHECK OF THE WARMING DEVICE SHOWED NO MALFUNCTION. WITH TEMPERATURE SET AT 105F, THE ACTUAL TEMPERATURE AT THE CENTER OF THE BASIN MEASURED 105.8F. MAXIMUM OBSERVED TEMPERATURE AROUND THE EDGE MEASURED 108.4F. THE INSIDE OF THE BASIN HAD RESIDUE THAT APPEARED TO BE PIECES OF MELTED DRAPE MATERIAL. WHEN THE DEVICE IS FIRST TURNED ON, THE EDGES OF THE BASIN GET EXTREMELY HOT BEFORE THE THERMOSTAT SENSOR GETS UP TO THE TEMPERATURE SET POINT. IF THERE ARE FOLDS IN THE DRAPE, HEAT IS NOT EFFECTIVELY TRANSFERRED FROM THE WATER TO THE BOTTOM OF THE BASIN, ALLOWING HOT SPOTS TO DEVELOP. ALL OF OUR OTHER WARMERS SHOW SIGNS OF DRAPE MELTING ON THE BOTTOM OF THE BASIN.ANYTIME THE STERILE DRAPE LEAKS, THERE IS POTENTIAL FOR PATIENT INFECTION. NO PATIENT INJURY HAS BEEN REPORTED SO FAR. IF THE BOTTOM OF THE WARMING BASIN HAD BETTER HEAT DISTRIBUTION THIS PROBLEM COULD BE MINIMIZED. USING A DRAPE MATERIAL WITH A HIGHER MELTING POINT WOULD ALSO HELP.WE HAVE HAD THIS PROBLEM REPEATEDLY OVER THE PAST FEW YEARS. AT LEAST 5-6 TIMES THAT I CAN REMEMBER THAT IT LOOKED LIKE A MELTING ISSUE. WE HAVE HAD PUNCTURE ISSUES WITH THE DRAPE CAUSED BY SHARP OBJECTS, BUT THAT IS CLEARLY OPERATOR ERROR. UNFORTUNATELY, IN MOST OF THE PREVIOUS CASES THE DRAPE WAS NOT SAVED (THEY ARE USUALLY CONTAMINATED WITH BLOOD). OR SOLUTIONS MAINTAINS THAT MELTING ONLY OCCURS WHEN THE DRAPE IS NOT PROPERLY SEATED IN THE BASIN AND FILLED WITH WATER, BUT WHEN YOU PUT A FLAT SHEET OF PLASTIC INTO A DEEP RECTANGULAR BASIN, THERE IS NO WAY TO AVOID FOLDS IN THE PLASTIC. WHILE IN SOME CASES, OPERATOR ERROR MAY HAVE CONTRIBUTED TO FAILURES, SEVERAL INCIDENTS HAPPENED WITH WELL TRAINED INDIVIDUALS WHO PAID ATTENTION TO THE INSTRUCTIONS AND ARE VERY FAMILIAR WITH THE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OR SOLUTIONS SOLUTION WARMER DWJ O.R. SOLUTIONS, INC. * 1208001

    Patients

    Seq Age Sex Outcome Treatment
    1 *