BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORS-300N SOLUTION WARMER DRAPE

    MDR report key: 5841400 · Received August 2, 2016

    Report

    Report Number
    8043817-2016-00044
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Report Date
    January 26, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K021288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ASSOCIATED WITH ITEM NUMBER OM-ORS-300, LOT NUMBER 1036670 AND IS ASSOCIATED WITH THE POTENTIAL FOLLOWING ORS-300N NON STERILE MICROTEK LOT NUMBERS, D152231, D152171A, AND D152211. D152231 WAS MANUFACTURED ON 8/12/2015, D152171A ON 08/10/2015 AND D152211 WAS A LOT NUMBER THAT WAS NOT ASSIGNED. NO DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE DEVICE HISTORY RECORD REVIEW, THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. SINCE A SAMPLE WAS NOT PROVIDED, THE NON-CONFORMITY COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER HAD AN INSTANCE OF A FLUID WARMER DRAPE MELTING AND CREATING A SMALL HOLE DURING USE IN THE O.R. THE TEAM PULLED THE WARMER FROM SERVICE AND BIOMED HAS EVALUATED TO FIND NO PROBLEM IN THE EQUIPMENT ITSELF. THE STAFF REPORTS THE DRAPES ARE MUCH THINNER NOW AND THEY ARE CONCERNED THE QUALITY CONTRIBUTED TO THIS BREAK IN STERILITY/INTEGRITY. THE TEMP WAS SET AT 120 DEGREES FAHRENHEIT AS PER PROPER USE AND HAS NO SETTINGS ABOVE THAT. MEDICAL ACTION IS A CONTRACTOR FOR THESE DRAPES AND A COMPLAINT WAS SUBMITTED TO MEDICAL ACTION AS WELL TO OBTAIN THE NONSTERILE PRODUCT AND LOT NUMBER USED TO PACKAGE THE STERILE DRAPE FROM MEDICAL ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494081 ORS-300N SOLUTION WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other