BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLUSH/WARMER

    MDR report key: 3940697 · Received April 22, 2014

    Report

    Report Number
    8043817-2014-00002
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ECOLAB-MICROTEK MEDICAL
    Product Code
    LHC
    PMA / PMN Number
    K021289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN AREA OF THE SLUSH/WARMER DISC- DRAPE OVERHEATED, BURNING A SMALL HOLE THAT ALLOWED THE SALINE SOLUTION IN THE WARMING DEVICE TO BECOME OVERHEATED. CONTAMINATION OF THE SALINE SOLUTION IN THE WARMING DEVICE IS CLEARLY UNACCEPTABLE BUT THIS CANNOT HAPPEN WHEN THE DEVICE IS PROPERLY OPERATED. AN INVESTIGATION BY (B)(4) ASSIGNED TO (B)(6), DETERMINED THAT A HOSPITAL EMPLOYEE TURNED ON THE DEVICE WITHOUT FIRST CHECKING TO MAKE SURE THAT THE DEVICE WAS READY TO OPERATE. USER INSTRUCTIONS EMPHASIZE THAT THERE MUST BE FLUID IN THE BASIN TO PREVENT SUCH AN OCCURRENCE. BIOMED GROUP AND ACCOUNT EXECUTIVE HAVE BEEN WORKING WITH THE HOSPITAL STAFF. THIS ISSUE WAS EXPLAINED TO THEM, THE EQUIPMENT WAS REPAIRED AND RUSH UNIVERSITY MEDICAL CENTER HAS ELECTED TO KEEP THIS DEVICE AS IT WORKS SATISFACTORILY WHEN PROPERLY OPERATED. WE BELIEVE NO FURTHER INVESTIGATION IS REQUIRED AS THE DEVICE WORKS AS INTENDED WHEN PROPERLY MAINTAINED AND OPERATED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 REC'D MEDWATCH REPORTED THROUGH EMAIL FROM (B)(6) LOCATION. THE COMPLAINT REPORTED WAS ABOUT THE HOLE ON THE ORS-320 SLUSH DRAPE. THE WARMER/SLUSH WAS OVERHEATED CAUSING A BURN AREA WITH A SMALL HOLE. THIS THEN CAUSED CONTAMINATION OF THE SALINE SOLUTION IN THE BASIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242605 SLUSH/WARMER SLUSH/WARMER LHC ECOLAB-MICROTEK MEDICAL ORS-320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR