BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5632412 · Received May 4, 2016

    Report

    Report Number
    8043817-2016-00030
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Report Date
    April 19, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K023282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE DHR REVIEW, THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIALS 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. SINCE NO SAMPLE WAS RETURNED FOR REVIEW, THE NON CONFORMITY COULD NOT BE CONFIRMED AND NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    BASED ON THE DHR REVIEW, THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIALS 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. SINCE NO SAMPLE WAS RETURNED FOR REVIEW, THE NON CONFORMITY COULD NOT BE CONFIRMED AND NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. FOLLOW UP #1: LOT 1053464 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO MICROTEK NONSTERILE LOTS D152651 AND D153091 THE DHR WAS REVIEWED FOR LOT D152651 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 9/22/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D153091 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 11/05/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. SINCE NO SAMPLE WAS RETURNED FOR REVIEW, THE NON CONFORMITY COULD NOT BE CONFIRMED AND NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AFTER COMPLETING A SURGICAL CASE, AN END USER DISCOVERED THAT THE SLUSH DRAPE HAD A TEAR IN THE DESIGNATED WARMER SIDE OF THE DRAPE. THE CST REMOVING THE USED DRAPE FOUND IT IS WAS LEAKING FLUID WHEN REMOVED FROM THE MACHINE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    AFTER COMPLETING A SURGICAL CASE, AN END USER DISCOVERED THAT THE SLUSH DRAPE HAD A TEAR IN THE DESIGNATED WARMER SIDE OF THE DRAPE. THE CST REMOVING THE USED DRAPE FOUND IT WAS LEAKING FLUID WHEN REMOVED FROM THE MACHINE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287341 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-321N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1