BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORS-320N SOLUTION WARMER DRAPE

    MDR report key: 5742870 · Received June 22, 2016

    Report

    Report Number
    8043817-2016-00035
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Report Date
    May 27, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K021288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ASSOCIATED WITH ITEM NUMBER OM-ORS-320 LOT NUMBER 1040522 AND IS ASSOCIATED WITH THE POTENTIAL FOLLOWING ORS-320N NON STERILE MICROTEK LOT NUMBERS, DA151751, D151521, D151811, D151471, D151461, D151591, D151681, AND D152461. AFTER EXAMINING THE RETURNED DEVICE, THE "HOLE" IN QUESTION APPEARS TO BE A BURN HOLE. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MANUFACTURING 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. BASED UPON THE EXAMINATION OF THE RETURNED PRODUCT, IT IS CONCLUDED THAT THIS EVENT WAS RELATED TO MISUSE BY THE CUSTOMER AND THEREFORE NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOLUTION WAS POOLING IN THE MACHINE UNDER THE DRAPE DURING AN AORTIC ANEURYSM REPAIR/AORTIC VALVE REPLACEMENT. THE MACHINE AND DRAPE WERE REMOVED AND REPLACED. THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THE ANESTHESIOLOGIST CHOSE TO RE DOSE THE PATIENT WITH AN ANTIBIOTIC POST-OP PER FACILITY PROTOCOL. A MEDWATCH HAS BEEN FILED FOR THIS INCIDENT BY MEDLINE AND THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398085 ORS-320N SOLUTION WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-320N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other