BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER MAXM W/AUTOLOADER

    MDR report key: 2171213 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00776
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K922704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR WAS ATTEMPTING TO EMPTY THE VACUUM TRAP JAR WHEN THE INJURY OCCURRED. THE RIGHT SIDE OF THE ANALYZER IS CLOSE TO A WALL, WHICH PREVENTS THE RIGHT DOOR FROM FULLY OPENING AND LIMITS ACCESS TO THE INSIDE. SERVICE WAS NOT DISPATCHED FOR THIS INCIDENT. THE OPERATOR WAS ABLE TO RESOLVE THE ISSUE AND RETURN THE ANALYZER TO PROPER FUNCTION. THE ROOT CAUSE FOR THE OPERATOR'S MINOR INJURY OF CUTTING HER KNUCKLE ON THE BRACKET CAN BE ATTRIBUTED TO THE LIMITED ACCESS TO THE RIGHT SIDE OF THE ANALYZER. ROOT CAUSE IS USER ERROR, DUE TO THE PLACEMENT OF THE ANALYZER CLOSE TO A WALL. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MINOR INJURY WHILE USING THE COULTER MAXM W/AUTOLOADER. WHILE TROUBLESHOOTING THE INSTRUMENT FOR A LOCK UP ERROR, THE OPERATOR CUT HER KNUCKLE ON THE PRESSURE/VACUUM TANK BRACKET MOUNTED INSIDE THE RIGHT SIDE DOOR. THE OPERATOR WAS ATTEMPTING TO EMPTY THE VACUUM TRAP JAR WHEN THE INJURY OCCURRED. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT AT TIME OF INCIDENT AND WAS NOT EXPOSED TO ANY BIOHAZARD FLUIDS. THE OPERATOR WASHED AND BANDAGED THE CUT, PUT ON NEW GLOVES, AND DID NOT SEEK MEDICAL ATTENTION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER MAXM W/AUTOLOADER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK