BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4070028 · Received September 8, 2014

    Report

    Report Number
    1061932-2014-02285
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08/13/2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND TUBING WITH A HOLE IN IT ON FEED-THROUGH FITTING (FF188) GOING TO PINCH VALVE (PV56) AND REPLACED IT TO RESOLVE ISSUE. 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. THE LEAK WAS AN UNDETERMINED AMOUNT OF CLEANER THAT LEAKED FROM THE ANALYZER ONTO THE COUNTER, WHILE RUNNING SAMPLES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES, GOGGLES, AND GOWN WHEN THE LEAK WAS DISCOVERED. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. 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
    547902 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1