BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3031836 · Received April 2, 2013

    Report

    Report Number
    1061932-2013-00475
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER SITE. THE FSE FOUND A PINHOLE IN TUBING LEAK AT PINCH VALVE PV37 WHICH HE REPLACED TO RESOLVE THE LEAK. FAILURE MODE WAS A PINHOLE LEAK IN TUBING AT PV37. HOWEVER, THE INSTRUMENT GENERATED AMBIENT TEMPERATURE ALARMS TO ALERT THE CUSTOMER TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) GETTING AMBIENT TEMPERATURE ALARMS AND ABOUT 30 ML OF CLEANER LEAKING UNDER THEIR COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER WHILE PERFORMING A STARTUP CYCLE. THE LEAK WAS NOT CONTAINED INSIDE THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF A LABORATORY COAT, GLASSES AND GLOVES. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT WAS REPORTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134651 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1