BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 HEMATOLOGY ANALYZER

    MDR report key: 3031729 · Received April 2, 2013

    Report

    Report Number
    1061932-2013-00497
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS SCHEDULED BUT WAS CANCELLED LATER AS THE CUSTOMER RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER LH500 HEMATOLOGY ANALYZER GENERATED "AMBIENT TEMPERATURE ERRORS" AND LEAKED CLEANING AGENT (CLENZ) IN THE AREA OF PELTIER MODULE AND ONTO THE COUNTER WHILE RUNNING PATIENT SAMPLES. THE CUSTOMER WAS WEARING A LAB COAT, GOGGLES AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS), BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THE CUSTOMER FOUND A HOLE IN TUBING FROM FF107 AT PINCH VALVE (PV) 37. THE CUSTOMER REPLACED TUBING ON PINCH VALVE (PV) 37 FROM FF107 AND FF105 RESOLVING THE LEAK. PINCH VALVE PV 37 PROVIDES PRESSURIZED DILUENT FROM THE SHEATH TANK TO MANIFOLD, MF11, AND ALSO PROVIDES VACUUM AND CLEANER TO PUMP, PM10. PER PHONE CONVERSATION WITH THE CUSTOMER THE INSTRUMENT WAS OPERATING WITH NO FURTHER LEAKS OBSERVED. THE "AMBIENT TEMPERATURE ERRORS" WAS ALSO RESOLVED AFTER REPLACING THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133741 COULTER® LH500 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1