BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2905651 · Received January 9, 2013

    Report

    Report Number
    1061932-2013-00027
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED BLUE-TINTED FLUID ON THE TABLE TOP BELOW THE ASPIRATION PROBE. THE FLUID LEAK WAS CAUSED BY A FAULTY PILOT ACTUATOR FOR LINE VL98. VL98 PROVIDES THE WASTE PATH FOR THE SEGMENT NEEDLE WASH FOR THE RANDOM ACCESS SHEAR VALVES. THE WASH CUP WAS ALSO DISCONNECTED FROM THE SHAFT ON THE PROBE-WIPE ASSEMBLY. THE FSE REPLACED THE FAULTY PILOT ACTUATOR AND RE-ATTACHED THE WASH CUP TO THE ACTUATOR SHAFT AND RESOLVED THE ISSUE. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEAR FLUID LEAKED AND PRECIPITATE AROUND THE RETIC SHEAR VALVE AND CHAMBER ASSEMBLY INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11628 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1