BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2224946 · Received August 26, 2011

    Report

    Report Number
    1061932-2011-01306
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, BEC FIELD SERVICE ENGINEER (FSE) CHECKED THE UNIT AND FOUND THE BELLOWS OVERFLOWING, AND VL13 NOT RELEASING. THE FSE REPLACED THE ACTUATOR AND THE PINCH VALVE AND FLUSHED THE VACUUM LINES. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THE RESULTS MET THE PUBLISHED PERFORMANCE SPECIFICATION. SYSTEM VALIDATION WAS DOCUMENTED IN THE CUSTOMER'S QC RECORD. ROOT CAUSE FOR THE LEAK IS ASSOCIATED TO A DEFECTIVE PINCH VALVE. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A BLOODY LEAK UNDER COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PPE INCLUDING GLOVES, LAB COAT, AND EYE PROTECTION AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANE OR OPEN WOUNDS. NO ONE SOUGHT MEDICAL ATTENTION. MSDS WAS NOT REVIEWED, BUT IS READILY AVAILABLE. THE FACILITY HAS EXPOSURE CONTROL PLAN. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1