BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3962210 · Received July 28, 2014

    Report

    Report Number
    1061932-2014-01756
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE CUSTOMER EMPTIED THE VACUUM TRAP AND RECONNECTED THE TUBING AT FEED-THROUGH FITTING (FF16) ON THE RBC (RED BLOOD CELL) BATH RESOLVING THE LEAK AND THE ERROR CONDITIONS. THE INSTRUMENT WAS VERIFIED WITH NO FURTHER LEAKING OBSERVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. APPROXIMATELY 10 ML OF CLEANER LEAKED FROM THE VACUUM TRAP OF THE INSTRUMENT WHEN TUBING AT FEED-THROUGH FITTING (FF16) HAD DISCONNECTED FROM THE RBC (RED BLOOD CELL) BATH. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT ALSO GENERATED ERROR CONDITIONS OF VACUUM AND RBC BATH OVERFLOW ERRORS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GOWN AND GLOVES WHEN THE LEAK WAS IDENTIFIED. 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
    439728 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1