BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3822263 · Received May 20, 2014

    Report

    Report Number
    1061932-2014-01123
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER EVALUATED THE INSTRUMENT AND FOUND PINCH VALVE PV28 HAD A PRESSURE LEAK. THE FSE REPLACED BOTH TUBINGS IN PV28 TO CORRECT THE PRESSURE LEAK. HE WAS UNABLE TO FIND ANY VISIBLE SIGNS OF A FLUID LEAK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS DESCRIBED AS ABOUT 10 CC OF CLENZ THAT LEAKED ONTO THE FLOOR. THE LEAK WAS NOT CONTAINED. THE CUSTOMER WAS GOING TO RUN A STARTUP WHEN SHE NOTICED THE INSTRUMENT LEAKED CLENZ DURING THE SHUTDOWN. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES. NO PATIENT SAMPLES WERE RUNNING WHEN THE LEAK WAS IDENTIFIED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES, GOWN, AND GOGGLES 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
    300617 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1