BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 HEMATOLOGY ANALYZER

    MDR report key: 2152251 · Received July 7, 2011

    Report

    Report Number
    1061932-2011-00847
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) INDICATED THAT THE CUSTOMER HAD REPAIRED THE LEAK IN PINCH VALVE PV58 PRIOR TO THE FSE'S ARRIVAL. DILUENT, CLENZ, LATRON, ISOTON, AND BLOOD PASS THROUGH PINCH VALVE PV58. THE ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A FLUID LEAK ON COULTER LH750 HEMATOLOGY ANALYZER. THE FLUID APPEARED TO BE LH DILUENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE AT THE CUSTOMER'S FACILITY. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED HOWEVER IT IS READILY AVAILABLE. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH750 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1