BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVI® COLOR V2

    MDR report key: 7925518 · Received October 2, 2018

    Report

    Report Number
    3002769706-2018-00190
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    September 2, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    KPA
    PMA / PMN Number
    C1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED FOR A CUSTOMER FROM THE UNITED STATES THAT REPORTED OPERATOR/USER INJURY IN ASSOCIATION WITH THE PREVI® COLOR V2 INSTRUMENT (REF 414292R). THE INVESTIGATION WAS PERFORMED BY THE SUPPLIER. THE MOST PROBABLE ROOT CAUSE(S): METHANOL LEAK INSIDE THE INSTRUMENT THAT COULD COME FROM THE CONNECTION BETWEEN THE INTERNAL TUBING AND THE TUBES WHICH PLUNGED INTO THE REAGENT BOTTLE. THEN METHANOL DRAINED ONTO THE MAT UNDER THE INSTRUMENT AND EVAPORATED ITSELF AROUND AND INSIDE THE INSTRUMENT. THE POWER SUPPLY BOARD WAS SHORTED BY FLUID DRIPPING OR SPLASHING ONTO THE COMPONENTS PROBABLY BY A SMALL DROP OF IODINE WHICH LED TO A SPARK. COMBINATION OF THE METHANOL VAPOURS AND THE SPARK MADE IGNITION OF FIRE WHICH SPREAD UP TO THE METHANOL'S WET MAT UNDER THE INSTRUMENT. IN ADDITION: CUSTOMER WAS USING METHANOL WITHOUT HOOD, WHICH IS NOT COMPLIANT WITH USER MANUAL (514726-1 EN 1-2013-12-EN-414292) PREVI COLOR V2 CYTOCENTRIFUGE ROTOR PAGE 9/93 - CHAPTER 1-2). CUSTOMER CONTINUED TO USE THE INSTRUMENT EVEN IF A LEAK WAS OBSERVED, WHICH IS NOT COMPLIANT WITH USER MANUAL (514726-1 EN 1-2013-12-EN-414292) PREVI COLOR V2 CYTOCENTRIFUGE ROTOR PAGE 9/93 - CHAPTER 1-2). ELITECH PROPOSED THAT ACTION BE TAKEN TO PROTECT THE POWER SUPPLY FROM ANY DROPS OF REAGENT THAT MAY OCCUR WITHIN ITS SURROUNDING.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OPERATOR/USER INJURY IN ASSOCIATION WITH THE PREVI® COLOR V2 INSTRUMENT (REF 414292R). THE CUSTOMER REPORTED THE FOLLOWING: ON (B)(6) 2018, A LAB TECHNICIAN HAD COMPLETED INSTRUMENT MAINTENANCE AND NOTICED THE ABSORBENT PAD UNDER INSTRUMENT WAS WET. ANOTHER TECHNICIAN LIFTED THE FRONT OF THE INSTRUMENT TO REMOVE THE PAD AND HEARD A CRACK. A LARGE SPARK CAME OUT AND HIT THE TECHNICIAN, AND THE PAD BURST INTO FLAMES. AT THAT POINT THE TECHNICIAN PULLED THE PLUG ON THE INSTRUMENT, PULLED THE FIRE ALARM AND LEFT THE ROOM. MAINTENANCE CAME IN AND PUT THE FIRE OUT AND WAITED FOR THE FIRE DEPARTMENT TO ARRIVE. THE FIRE DEPARTMENT DETERMINED THE FIRE WAS OUT. THE CUSTOMER REPORTED THAT TWO TECHNICIANS WENT TO THE EMERGENCY ROOM WITH INJURIES: THE TECHNICIAN THAT WAS HIT BY THE SPARK HAD A BURN ON THE PALM OF THE LEFT HAND. THE ER TREATED THE WOUND WITH OINTMENT. ONE TECHNICIAN HAD REDNESS ON THE ARM AND ELEVATED BLOOD PRESSURE, SHE WAS OBSERVED FOR ABOUT AN HOUR WITH NO FURTHER TREATMENT. BOTH TECHNICIANS WERE RELEASED. TO BE NOTED, METHANOL IS APPROVED FOR USE WITH THIS SYSTEM; HOWEVER, THE USER MANUAL STATES TO ALWAYS OPERATE THE INSTRUMENT UNDER A SAFETY HOOD WHEN IN USE. CUSTOMER CONFIRMED THEY DO USE METHANOL WITH THIS INSTRUMENT, BUT THAT THEY DO NOT HAVE THIS INSTRUMENT UNDER A SAFETY HOOD. THE INSTRUMENT WAS SENT IN FOR FURTHER EVALUATION. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765916 PREVI® COLOR V2 PREVI® COLOR V2 KPA BIOMERIEUX, SA 414292R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention