BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDEPREP PLUS CYTOLOGY CENTRIFUGE

    MDR report key: 2711026 · Received August 16, 2012

    Report

    Report Number
    1721649-2012-00001
    Event Type
    Malfunction
    Date Received
    August 16, 2012
    Date of Event
    July 20, 2012
    Report Date
    August 15, 2012
    Manufacturer
    SEPARATION TECHNOLOGY, INC. PART OF THERMO FISHER SCIENTIFIC
    Product Code
    IFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE LID OF THE SLIDEPREP PLUS CYTOLOGY CENTRIFUGE WAS OPEN AND THE OPERATOR WAS PUTTING SLIDES INTO IT WHEN THE ROTOR BEGAN TO SPIN ON ITS OWN. THE OPERATOR NOTICED THE ROTOR BEGINNING TO SPIN AND PULLED HIS HAND AWAY BEFORE ANY INJURIES OCCURRED. THE CUSTOMER RETURNED THE DEVICE TO SEPARATION TECHNOLOGY, INC ON (B)(6) 2012 UNDER RGA 34447. INITIAL ATTEMPTS TO DUPLICATE THE FAILURE WERE UNSUCCESSFUL. CUSTOMER CONTACTED ON (B)(6) 2012, FOR MORE DETAILS REGARDING THE INCIDENT TO HELP WITH DUPLICATING THE FAILURE. CUSTOMER RESPONDED WITH AN E-MAIL ON (B)(6) 2012, THAT PROVIDED LITTLE ADDITIONAL DETAIL REGARDING THE INCIDENT OTHER THAN TO SAY THAT THE ROTOR DID NOT STOP TURNING WHEN THE STOP BUTTON WAS PRESSED, SO THE POWER SWITCH WAS TURNED TO OFF TO STOP THE ROTOR. ADDITIONAL ATTEMPTS TO CAUSE THE ROTOR TO TURN WITH THE LID OPEN WERE NOT SUCCESSFUL. ON (B)(6) 2012, THE DEVICE WAS OPENED TO INSPECT THE INSIDE. THE MOTOR GROUND WIRE, WHICH IS THE MOST LIKELY CAUSE OF THIS FAILURE, WAS TIGHT. NO OBVIOUS CAUSES TO THE FAILURE COULD BE FOUND. A JUMPER WIRE WAS FOUND TO BE PINCHED, BUT WITH NO METAL WIRE EXPOSED THROUGH THE INSULATION. A CONTINUITY TEST OF THE WIRE REVEALED NO ADVERSE EFFECT OF THE PINCHING. ON (B)(6) 2012, FURTHER INSPECTIONS WERE CONDUCTED BY AN ELECTRICAL ENGINEER. NO ABNORMALITIES COULD BE FOUND INSIDE THE DEVICE. THE ENGINEER TRIED WIGGLING AND VIBRATING KEY COMPONENTS OF THE DEVICE TO TRIGGER THE ROTOR MOTOR, WITH NO SUCCESS. THE ENGINEER CLOSED THE DEVICE AND BEGAN OPERATING IT AT VARIOUS SPEEDS, AND TRIED LOADING AND UNLOADING THE ROTOR TO TRIGGER THE MOTOR TO START, ALSO WITH NO SUCCESS. AS OF (B)(6) 2012, TESTING HAD STILL NOT BEEN ABLE TO DUPLICATE THE FAILURE. TESTING SHALL CONTINUE AND A FOLLOW-UP REPORT SHALL BE COMPLETED ONCE ALL POSSIBLE CAUSES ARE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIDEPREP PLUS CYTOLOGY CENTRIFUGE SLIDEPREP PLUS IFB SEPARATION TECHNOLOGY, INC. PART OF THERMO FISHER SCIENTIFIC 100-400 033

    Patients

    Seq Age Sex Outcome Treatment
    1