BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD BACTEC FX - TOP UNIT

    MDR report key: 1619871 · Received February 26, 2010

    Report

    Report Number
    1119779-2010-00001
    Event Type
    Other
    Date Received
    February 26, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 24, 2010
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    JTA
    PMA / PMN Number
    K915796A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACTEC FX INSTRUMENT WAS DESIGNED TO MEET (B)(4), UL AND INT'L STABILITY REGULATIONS. AFTER PROPER INSTALLATION, ALL SALEABLE CONFIGURATIONS OF THE BACTEC FX, USING WORST CASE SCENARIOS INCLUDING THE ONE DESCRIBED IN THIS REPORT, WERE TESTED FOR OVERBALANCING (TIPPING OVER). EACH CONFIGURATION PASSED ALL CRITERIA. THE INSTRUMENT HAS WHEELS THAT ALLOW FOR EASY TRANSPORTATION DURING INSTALLATION. ONCE THE INSTRUMENT REACHES THE INSTALLATION LOCATION, ALL FOUR INSTRUMENT FEET SHOULD BE COMPLETELY EXTENDED TO MAKE CONTACT WITH THE FLOOR TO BECOME THE LOAD BEARING COMPONENTS OF THE INSTRUMENT'S WEIGHT AND THEN THE INSTRUMENT IS LEVELED. THE WHEELS SHOULD NOT BEAR ANY WEIGHT AND WILL SPIN FREELY ONCE THE FEET ARE PROPERLY PLACED. THE SERVICE ENGINEER WHO INSTALLED THE INSTRUMENT DID NOT COMPLETE THE REQUIRED INSTALL CHECK LIST FROM THE BD BACTEC FX SYSTEM INSTALLATION PROCEDURE. IT IS UNCLEAR WHETHER THE UNIT WAS NOT PROPERLY SET UP DURING INSTALL OR WAS ALTERED/MOVED BY THE CUSTOMER. THE INSTRUMENT STILL HAD ONE WHEEL IN CONTACT WITH THE GROUND AND ONLY THREE FEET WERE PROPERLY PLACED AND LEVELED. MULTIPLE WARNING APPEARS IN THE CURRENT INSTALLATION PROCEDURE USED BY THE ENGINEER TO INSTALL THE UNIT AS WELL AS THE CUSTOMER USER'S MANUAL. CUSTOMERS ARE INSTRUCTED TO CONTACT BD PRIOR TO MOVING THE UNIT. ENGINEERS WILL BE RETRAINED TO THE CURRENT PROCEDURE, TRAINING WILL BE DOCUMENTED AND EFFECTIVENESS WILL BE EVALUATED. THIS CORRECTIVE ACTION IS BEING DOCUMENTED WITHIN THE CAPA SYSTEM. BD WILL CONTINUE TO CLOSELY MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER RECENTLY HAD A BACTEC FX INSTRUMENT PARTIALLY INSTALLED IN THE LABORATORY. THE CUSTOMER HAD A "STACK" CONFIGURATION WHICH IS 2 UNITS STACKED ONE ON TOP OF THE OTHER. WHEN THE CUSTOMER OPENED A FULLY LOADED DRAWERS FROM EACH UNIT THE STACK BEGAN TO MOVE FORWARD AND START TO TOPPLE. ANOTHER TECH WAS CLOSE BY AND ASSISTED TO STABILIZE THE INSTRUMENT AVOIDING ANY INJURY TO EITHER TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD BACTEC FX - TOP UNIT JTA BD DIAGNOSTIC SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other