BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3900741 · Received June 27, 2014

    Report

    Report Number
    1061932-2014-01369
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND REPLACED THE BLOOD SAMPLING VALVE (BSV) AND PERFORMED ADDITIONAL WORK ON THE SOLENOIDS AND ACTUATORS TO RESOLVE THE HIGH HGB AND MCHC AS WELL AS THE VOTE OUTS FOR THE WBC AND PLT PARAMETERS. THE LEAK WAS RESOLVED BY THE CUSTOMER BY REATTACHING THE TUBING AT PORT 7 ON THE BSV. THE FSE ALSO REPORTED THAT THE HIGH HGB AND MCHC RESULTS WERE FLAGGED BY INSTRUMENT RULES TO ALERT THE OPERATOR OF AN ISSUE AND THE OPERATOR PROCEEDED TO REPEAT THE SAMPLES ON AN ALTERNATE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE TUBING AT PORT 7 ON THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER STATED THAT APPROXIMATELY TWENTY-FIVE MILLILITERS (25 ML) OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND SAFETY GLASSES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE AND THE CUSTOMER STATED THAT THE TUBING ON PORT 7 OF THE BSV HAD DISCONNECTED AND SQUIRTED LIQUID ONTO THE TABLE SURFACE. THE CUSTOMER REATTACHED THE TUBING BUT THE TUBING DISCONNECTED AGAIN. THE CUSTOMER REATTACHED THE TUBING AGAIN BUT THE INSTRUMENT GENERATED VOTE OUTS (NON-NUMERICAL RESULT) FOR THE WHITE BLOOD CELL (WBC) AND PLATELET (PLT) PARAMETERS, AND HIGH HEMOGLOBIN (HGB) AND MEAN CORPUSCULAR VOLUME CONCENTRATION (MCHC) RESULTS. THERE WAS NO REPORT OF CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378337 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1