BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TRIAC CENTRIFUGE

    MDR report key: 3101832 · Received May 1, 2013

    Report

    Report Number
    1119779-2013-00004
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    THE DRUCKER COMPANY
    Product Code
    GKG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BD TRIAC CENTRIFUGE IS A MULTI-SPEED, TABLE-MODEL CENTRIFUGE DESIGNED TO OPERATE IN THE FOLLOWING THREE MODES: MHCT MODE: TO OBTAIN QUANTITATIVE MICRO-HEMATOCRITS FROM WHOLE BLOOD. BLOOD MODE: TO OBTAIN URINE SEDIMENTATIONS FOR MICROSCOPIC EXAMINATION. THE CENTRIFUGE IS EQUIPPED WITH A LID SAFETY SWITCH. WHEN THE LID IS CLOSED AND PROPERLY LATCHED, A SAFETY WITCH IS ENGAGED, ACTIVATING THE MOTOR. THE CENTRIFUGE WAS RETURNED TO BD FOR INVESTIGATION. IT WAS CONFIRMED THAT THE CENTRIFUGE DID SPIN WITH THE LID IN THE OPEN POSITION. IT WAS DETERMINED THAT THE ACTUATOR SPRING WAS JAMMED ONTO, AND TO THE SIDE OF THE SAFETY SWITCH. WHEN THE JAM WAS RELEASED THE INSTRUMENT BEGAN FUNCTIONING AS INTENDED. DURING ASSEMBLY THE OPERATION OF THE SAFETY SWITCH IS CONFIRMED FOR 100% OF THE UNITS MANUFACTURED. THE DEVICE HISTORY RECORD WAS REVIEWED. ALL PARTS AND CONSTRUCTION PROCESSES WERE FOLLOWING ACCORDINGLY. COMPLAINT TRENDING WAS PERFORMED. THERE IS NO TREND ON THIS TYPE OF DEFECT NOTED. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME AS THIS APPEARS TO BE AN ISOLATED EVENT. BD WILL CONTINUE TO TREND ON THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    A CUSTOMER WAS PLACING SPECIMENS INSIDE THE TRIAC CENTRIFUGE WHEN THE UNIT STARTED TO SPIN WITH THE LID IN THE OPEN POSITION. THE USER IMMEDIATELY WITHDREW THEIR HAND AND TURNED OFF THE UNIT. THE UNIT WAS BOXED UP FOR RETURN FOR INVESTIGATION. THE USER HAD PURCHASED THE UNIT AND REC'D IT ON (B)(6) 2013 AND HAD SUCCESSFULLY USED THE INSTRUMENT WITHOUT INCIDENT UNTIL THIS DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190372 BD TRIAC CENTRIFUGE GKG THE DRUCKER COMPANY 420200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other