BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4201333 · Received October 27, 2014

    Report

    Report Number
    1061932-2014-02667
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD ALREADY REPAIRED THE LEAK WHEN A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE. THE CUSTOMER FOUND A HOLE IN THE TUBING THROUGH PINCH VALVE VL17 WHICH CONTROLLED THE VACUUM FOR THE BATH OVERFLOW CHAMBER VC10. THE CUSTOMER REPLACED THE TUBING THROUGH PINCH VALVE VL17 AND THE INSTRUMENT RAN WITHOUT ANY LEAKS OR ERRORS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED FLUID LEAK OF APPROXIMATELY THREE (3) ML FROM THE PINCH VALVE VL17 OF THE COULTER LH 750 HEMATOLOGY ANALYZER INSTRUMENT. THE INSTRUMENT WAS GENERATING "LOW VACUUM" ERRORS WHEN THE LEAK WAS OBSERVED. THERE WAS NO REPORT OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND LABORATORY COAT WHEN THE LEAK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683161 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1