BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMO SCIENTIFIC

    MDR report key: 2474359 · Received February 27, 2012

    Report

    Report Number
    MW5024444
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    December 28, 2011
    Report Date
    February 8, 2012
    Manufacturer
    THERMO FISHER SCIENTIFIC
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 AT APPROXIMATELY 1030, ONE OF THE PHARMACY TECHNICIANS NOTICED A "BURNING SMELL" THAT WAS ORIGINATING FROM THE BIOLOGICAL SAFETY CABINET. THE TECHNICIAN WAS IMMEDIATELY INSTRUCTED TO TURN OFF THE HOOD. A CERTIFIED THERMO FISHER SCIENTIFIC SERVICE PERSON REMOVED THE COVER-PLATE ON THE BIOLOGICAL SAFETY CABINET AND NOTED THAT THE COMPUTERIZED MOTOR SPEED CONTROL BOARD HAD BURNT. HE ALSO COMMENTED THAT THE POWER SUPPLY WIRE TO THE ELECTRICAL MOTOR FROM THE CONTROL BOARD HAD REACHED SUCH A HIGH TEMPERATURE THAT IT HAD DISINTEGRATED WHEN HE REMOVED IT. THE WIRING DIAGRAMS INDICATED 16-18 GAUGE WIRING IN THE UNIT. THE SERVICE TECHNICIAN NOTED THAT THE BIOLOGICAL SAFETY CABINET WAS USING ALMOST 13.5 AMPS. THE MOTOR SPEED CONTROL BOARD WAS REPLACED AND THE ELECTRICAL REQUIREMENTS DECREASED. THERE HAVE BEEN OTHER REPAIR ISSUES WITH THIS BIOLOGICAL SAFETY CABINET. THIS IS DEFINITELY A QA ISSUE THAT COULD HAVE LED TO A CATASTROPHIC FIRE IN AN ONCOLOGY FACILITY. THIS PARTICULAR BIOLOGICAL SAFETY CABINET IS UTILIZED TO COMPOUND MANY OF THE PHASE I DRUGS IN OUR ONCOLOGY PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMO SCIENTIFIC THERMO ELECTRON FORMA CLASS II, A2 BIOLOGICAL SAFETY CABINET LXG THERMO FISHER SCIENTIFIC 1286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other