BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDEPREP PLUS CYTOLOGY CENTRIFUGE

    MDR report key: 3102268 · Received May 1, 2013

    Report

    Report Number
    1721649-2013-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    August 1, 2012
    Report Date
    April 2, 2013
    Manufacturer
    SEPARATION TECHNOLOGY, INC., PART OF THERMO FISHER SCIENTIFIC
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SLIDEPREP PLUS CYTOLOGY CENTRIFUGE OPERATOR'S MANUAL, REVISION E, MADE EFFECTIVE 08/2011, REVEALED THAT THE INSTRUCTION "MAKE SURE THAT THE LID IS SECURELY FITTED" IS PROVIDED IN BOLD, ALL CAPITAL LETTERS WITH A CAUTION SYMBOL IN SECTION 3.1, LOADING AND BALANCING THE SEALED HEAD. THE OPERATOR'S MANUAL IS SUFFICIENT FOR INSTRUCTING THE USER TO VERIFY THAT THE BOWL LID IS SECURELY ATTACHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES, "INNER CIRCULAR LID WORKS ITSELF LOOSE AND CAUSES OUTER LID TO POP OPEN WHEN IN USE AND INNER LID FLIES ACROSS THE ROOM AND HAS COME CLOSE TO HITTING PEOPLE IN IT'S PATH." DURING A PHONE CALL ON (B)(6) 2013, THE CUSTOMER REPORTED THAT THE INCIDENT OCCURRED TWICE. IN AN EMAIL ON (B)(6) 2013, THE CUSTOMER ESTIMATED THAT THE FIRST INCIDENT OCCURRED IN (B)(6) 2012, AND THE SECOND OCCURRED APPROX ONE MONTH LATER. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT WAS RETURNED TO STI FOR EXAMINATION ON (B)(6) 2013. OTHER THAN EVIDENCE OF NORMAL WEAR, A VISUAL EXAMINATION OF THE DEVICE REVEALED NO MECHANICAL OR OTHER FAILURES THAT COULD RESULT IN THE BOWL LID COMING OFF OF THE BOWL WHEN USED PROPERLY. PERFORMED TESTING OF THE DEVICE WAS ALSO CONDUCTED ON (B)(4) 2013. PRIOR TO THE TEST, THE BOWL LID WAS SECURED TIGHTLY TO THE BOWL AS INSTRUCTED IN THE OPERATOR'S MANUAL. THE BOWL LID SHOWED NO SIGNS OF COMING OFF DURING USE. ANOTHER TEST WAS CONDUCTED IN WHICH THE BOWL LID WAS ATTACHED TO THE BOWL LOOSELY. THE BOWL LID THEN CAME OFF AFTER ABOUT FOUR MINS OF OPERATION, BUT THE BOWL LID DID NOT CAUSE THE OUTER LID TO COME OPEN AS DESCRIBED IN THE CUSTOMER'S ALLEGATION. THE BOWL LID STAYED CONTAINED WITHIN THE CENTRIFUGE AFTER IT CAME OFF. THE IMBALANCE DETECTION SYSTEM ON THE CENTRIFUGE CAUSED IT TO STOP OPERATION ALMOST IMMEDIATELY AFTER THE BOWL LID CAME OFF. EFFORTS TO FORCE OPEN THE OUTER LID DURING OPERATION WERE NOT SUCCESSFUL, INDICATING THAT THE OUTER LID LATCH PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190831 SLIDEPREP PLUS CYTOLOGY CENTRIFUGE SLIDEPREP PLUS JQC SEPARATION TECHNOLOGY, INC., PART OF THERMO FISHER SCIENTIFIC 100-400

    Patients

    Seq Age Sex Outcome Treatment
    1