BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3000591 · Received March 12, 2013

    Report

    Report Number
    1061932-2013-00328
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING OVER THE PHONE AND HAD THE CUSTOMER REPLACE THE LOWER SHEATH RESTRICTOR TUBING WHICH RESOLVED THE LEAK (THE SHEATH FLOW RESTRICTOR RESTRICTS THE UPPER SHEATH FLOW AND DIRECTS IT INTO FLOW CELL PORT 3 DURING SAMPLE ANALYSIS). THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE LOWER SHEATH RESTRICTOR TUBING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK OF APPROXIMATELY 10ML OF CLEAR LIQUID AROUND THE RANDOM ACCESS MODULE AND TRIPLE TRANSDUCER MODULE AREA IN A COULTER LH 750 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABCOAT, GLOVES AND GLASSES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102907 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1