BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3183197 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01237
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND WAS NOT ABLE TO FIND OR REPRODUCE AN ACTIVE LEAK. THE FSE PERFORMED TROUBLESHOOTING FOR RADIO-FREQUENCY (RF) ERRORS AND STATED THERE WAS NO 300 VOLTS PRESENT, INCONSISTENT LATRON AND THE UNIT WAS INOPERABLE. THE FSE REPLACED THE DIFFERENTIAL POWER SUPPLY BOARD THAT RESTORED POWER, AND THE FLOW CELL CABLE THAT IMPROVED THE LATRON RF CONSISTENCY AND ELIMINATED THE RF VOLTAGE ERRORS. FAILURE MODE FOR THE REPORTED LEAK IS UNKNOWN AS THE FSE WAS UNABLE TO FIND OR REPRODUCE AN ACTIVE LEAK. FAILURE MODE FOR THE RF VOLTAGE ERRORS WAS ATTRIBUTED TO PREMATURE FAILURE ON THE RF PREAMP AND THE DIFFERENTIAL POWER SUPPLY BOARDS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT THERE WAS A LEAK OF BLOOD UNDER THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS LESS THAN 1ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER INDICATED THAT THE ANALYZER GENERATED RADIO-FREQUENCY (RF) VOLTAGE ERRORS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT, EYEGLASSES AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283875 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1