BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3203616 · Received July 3, 2013

    Report

    Report Number
    1061932-2013-01247
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED THAT THE SOURCE OF THE LEAK WAS AN OVERFLOW OF THE DIFFERENTIAL WASTE CHAMBER DURING SHUTDOWN. THE FSE STATED THAT THE DRAIN PRESSURE PORT WAS PLUGGED. THE FSE UNPLUGGED THE PORT AND THE PRESSURE DRAINED THE CHAMBER AS EXPECTED. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE CAUSE OF THE LEAK WAS THE DRAIN PRESSURE PORT OF THE DIFFERENTIAL WASTE CHAMBER WAS PLUGGED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT WHILE RUNNING CONTROLS A LEAK WAS DISCOVERED ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THE LABORATORY¿S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, GOGGLES, AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. NO PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305074 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1