BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3597702 · Received January 29, 2014

    Report

    Report Number
    1061932-2014-00215
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND A LOOSE ASPIRATE LINE AT THE NEEDLE CARTRIDGE WHILE ONSITE. HE TRIMMED AND RECONNECTED THE LOOSE LINE (TUBING) RESOLVING THE LEAK. THE FSE FLUSHED THE VACUUM SYSTEM WITH DISTILLED WATER THROUGH PV70 AND CLEANED THE VACUUM TRAP TO ELIMINATE THE ERROR MESSAGES. FAILURE MODE WAS IDENTIFIED: THE FAILURE MODE IDENTIFIED WAS LOOSE ASPIRATE LINE AT THE NEEDLE CARTRIDGE AND UNCLEAN VACUUM LINE. NO ERRONEOUS RESULTS WERE GENERATED FOR THIS EVENT. UPON RECUR OF THE FAILURE MODE IDENTIFIED (LOOSE LINE AT NEEDLE CARTRIDGE); IT IS LIKELY TO CAUSE UN-FLAGGED (ERRONEOUS), FLAGGED, OR NON-NUMERIC RESULTS FOR ALL PARAMETERS DUE TO IMPROPER SAMPLE QUALITY BEFORE IT IS ASPIRATED. HIGH VACUUM FAILURES IS A HAZARD ASSOCIATED WITH UNCLEAN VACUUM LINE FAILURE, FOR WHICH THE HIGH VACUUM SENSOR ERRORS ARE THE FAIL-SAFE. EVALUATION OF PRODUCT LABELING: BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THE BECKMAN COULTER (BEC) INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS DESCRIBED AS APPROXIMATELY 1-2 ML OF FLUID LEAKED FROM THE NEEDLE OF THE INSTRUMENT. THE LEAK WAS NOT CONTAINED. ERROR CONDITIONS OF "ASPIRATION ERRORS AND PC 1 COUNT ERRORS" WERE GENERATED FOR QUALITY CONTROL SAMPLES. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES, FACE PROTECTION, AND LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64314 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1