BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASP - SLIDE PREP EVO¿

    MDR report key: 14196009 · Received April 25, 2022

    Report

    Report Number
    8020790-2022-00049
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    April 15, 2022
    Report Date
    May 24, 2022
    Manufacturer
    COPAN WASP S.R.L
    Product Code
    JTC
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN FRANCE, WORKING ON A COPAN WASP, ATTEMPTED TO CLEAN DUST FROM THE SLIDE PREP EVO WITH A CAN OF DRY FLAMMABLE AIR. THE FLAMMABLE AIR DIFFUSED INTO THE WASP; A FLAME WAS GENERATED AND THE CUSTOMER WAS SLIGHTLY INJURED; THE FIRE DEPARTMENT WAS CALLED. THE CUSTOMER IMMEDIATELY CLOSED THE HOOD AND TURNED OFF THE POWER TO THE UNIT. BIOMÉRIEUX INFORMED COPAN (WASP MANUFACTURER) OF THE NEED FOR INVESTIGATION AND OF THE REPORT TO THE APPROPRIATE COMPETENT AUTHORITIES. INVESTIGATION BY BIOMÉRIEUX (GLOBAL CUSTOMER SERVICE): THE USER WANTED TO CLEAN THE SLIDE PREP EVO WITH A FLAMMABLE AIR SPRAY WHILE THE EQUIPMENT WAS STILL IN OPERATION. IN THE USER MANUAL, IT IS CLEARLY STATED THAT : - THE EQUIPMENT MUST BE CLEANED BY SUCTION OR WITH A WIPE; IT IS NOT INDICATED THAT CLEANING CAN BE DONE WITH A FLAMMABLE AIR SPRAY. - CLEANING MUST BE CARRIED OUT WITH THE EQUIPMENT SWITCHED OFF. THESE TWO INSTRUCTIONS WERE NOT FOLLOWED BY THE CUSTOMER. THE OCCURRENCE IS A RESULT OF HUMAN ERROR ON THE PART OF THE CUSTOMER. INVESTIGATION BY COPAN: THE INVESTIGATION SHOWS THAT THE EQUIPMENT HAS NO CONNECTION WITH THE INCIDENT; NO MALFUNCTION OCCURRED. THE USE OF FLAMMABLE AIR SPRAY BY THE CUSTOMER CAUSED THE FLAMES. AFTER INSPECTION BY A FIELD SERVICE ENGINEER (FSE), IT WAS DETERMINED THE EQUIPMENT WAS NOT DAMAGED. IN THE USER MANUAL, THERE ARE TWO SEPARATE PARTS FOR CLEANING; ONE PART FOR THE USER, ONE PART FOR THE BI-ANNUAL MAINTENANCE OF THE EQUIPMENT. IN NO CASE IS IT RECOMMENDED TO USE FLAMMABLE AIR SPRAY FOR CLEANING. THE CLEANING METHODS ARE WELL DESCRIBED. THIS IS A USER ERROR. RETROSPECTIVE ANALYSIS FOR THE PAST THREE YEARS IDENTIFIED THERE HAS BEEN NO SIMILAR OCCURRENCE. BASED ON COPAN'S RISK ASSESSMENT RESULTS, IT IS NOT CONSIDERED NECESSARY TO MAKE ANY IMMEDIATE UPDATES TO THE USER MANUAL BECAUSE THE MAINTENANCE FLOW IS CLEARLY EXPLAINED AND EXCLUDES ANY OTHER PROCEDURE NOT EXPLICITLY DESCRIBED. HOWEVER, THE EVENT WILL BE SHARED WITH THE TRAINING DEPARTMENT SO THAT THEY CAN INCLUDE AN ADDITIONAL WARNING IN THE NEXT REVISION OF THE USER MANUAL.

    Description of Event or Problem · 0

    INTENDED USE: THE WASP® (WALK AWAY SPECIMEN PROCESSOR) INSTRUMENT IS AN AUTOMATED MICROBIOLOGY SPECIMEN PROCESSING INSTRUMENT. IT IS AN OPEN PLATFORM THAT AUTOMATES PROTOCOLS FOR HIGH QUALITY PROCESSING REGARDLESS OF CONTAINER OR SPECIMEN TYPE, SUCH AS SWABS, LIQUID SPECIMENS, URINE, OR FECES. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF AN OPERATOR HARMED IN ASSOCIATION WITH SLIDE PREP EVO¿ - W086-40N WHILE USING THE WASP COPAN INSTRUMENT (SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT WHILE TRYING TO CLEAN THE DUST FROM THE SLIDE PREP EVO WITH DRY AIR, A FLAME WAS GENERATED. THE CUSTOMER IMMEDIATELY CLOSED THE COVER AND REMOVED THE POWER TO THE DEVICE. THE CUSTOMER WAS SLIGHTLY INJURED, THE FIRE DEPARTMENT WAS CALLED. WITHOUT THE INTERVENTION OF THE FIRE DEPARTMENT, AND WITHOUT A FIRE EXTINGUISHER, THE FLAME EXTINGUISHED ITSELF. IT WAS STATED THAT THE CUSTOMER WAS TRAUMATIZED BY THE INCIDENT AND WAS ATTENDED TO BY THE FIRE DEPARTMENT. IT WAS REPORTED THAT THE CUSTOMER¿S EYEBROWS AND HAIR WERE BURNED, AND HER FACE WAS SCALDED WITHOUT INJURY TO THE EYES. AN OPERATOR ERROR IS SUSPECTED. USER PREVENTIVE MAINTENANCE IFU INDICATE THAT SPRAY IS NOT ALLOWED TO USE ON SYSTEM DUE TO HOT SPOT WITH INCINERATOR AND ELECTRONICS FROM LASER PRINTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER FOR FURTHER INVESTIGATION AND A BIOMÉRIEUX FIELD SERVICE ENGINEER WAS SCHEDULED TO VISIT THE CUSTOMER¿S SITE TO CHECK IF THE INSTRUMENT CAN BE USED. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170728 WASP - SLIDE PREP EVO¿ SLIDE PREP EVO¿ JTC COPAN WASP S.R.L

    Patients

    Seq Age Sex Outcome Treatment
    1 Female