BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 2983628 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00269
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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
    WI, 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 OBSERVED THAT THE INSTRUMENT WAS GENERATING "CASSETTE NOT LOWERED INTO BED" ERROR MESSAGES AND THE CORNER OF THE APERTURE HOUSING WAS DAMP. THE LEAK WAS CAUSED BY A SMALL HOLE IN THE DRAIN TUBING FOR THE WHITE BLOOD CELL (WBC) BATH. THE FSE REPLACED THE AFFECTED TUBING, AND NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE FSE FOUND THAT THE CAUSE OF THE CASSETTE ERROR MESSAGES WAS THE ROCKERBED RIBBON CABLE WAS NOT WORKING PROPERLY. THE FSE REPLACED THE ROCKERBED RIBBON CABLE AND THE INSTRUMENT RAN WITHOUT INCIDENT. THE FSE INDICATED THAT THE CASSETTE ERROR MESSAGES WERE NOT GENERATED AS A RESULT OF THE LEAK; IT WAS AN UNRELATED OCCURRENCE. THE CAUSE OF THE LEAK WAS A SMALL HOLE IN THE DRAIN TUBING OF THE WBC BATH. THE CAUSE OF THE CASSETTE ERROR MESSAGES WAS ROCKERBED RIBBON REQUIRING REPLACEMENT. THE INSTRUMENT OPERATED AS INTENDED BY GENERATING AN ERROR MESSAGE ALERTING THE OPERATOR OF AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE COULTER LH 750 HEMATOLOGY ANALYZER WAS GENERATING "CASSETTE NOT LOWERED ON BED" ERROR MESSAGES AND WAS LEAKING IN THE BATH AREA. THE VOLUME OF THE LEAK WAS UNKNOWN AND WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LAB'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THIS EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AND PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87500 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1