BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3790703 · Received May 5, 2014

    Report

    Report Number
    1061932-2014-00977
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED TUBING DISCONNECTED FROM THE CHECK VALVE (CV6) AT THE SWEEP FLOW (SF1) TO RESOLVE THE LEAK AND VOTEOUT ISSUES. HE ALSO REPLACED THE MIXING CHAMBER (MC1) ELECTRICAL HARNESS, SOLENOID BLOCK (MF15) FOR THE MIX MODULE AND THE PELTIER (PLB1) FAN, WHICH WERE ALL DAMAGED BY THE LEAK. FSE THEN PERFORMED VERIFICATION OF INSTRUMENT TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. AN UNDETERMINED AMOUNT OF DILUENT LEAKED FROM THE INSTRUMENT AND ONTO THE FLOOR. THE INSTRUMENT ALSO GENERATED AN ERROR CONDITION OF VOTE-OUTS (NON-NUMERICAL RESULTS) FOR THE RED BLOOD CELL (RBC) AND PLATELET (PLT) PARAMETERS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT WHEN THE LEAK WAS IDENTIFIED. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO BIOHAZARD EXPOSURE REPORTED. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266596 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1