BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3277536 · Received August 10, 2013

    Report

    Report Number
    1061932-2013-01726
    Event Type
    Malfunction
    Date Received
    August 10, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE VC11 DRAIN TUBING TO RESOLVE THE LEAK AND RBC RECOVERY ISSUE AND REPLACED THE HGB LAMP AND HARNESS. FAILURE MODE: THE CAUSE OF THE LEAK WAS ATTRIBUTED TO THE VC11 DRAIN TUBING. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING HAVING ISSUES WITH HEMOGLOBIN (HGB) INCOMPLETE VALUES (NON-NUMERIC INSTRUMENT GENERATED FLAGS) ON THE COULTER LH 750 HEMATOLOGY ANALYZER. BEC CUSTOMER TECHNICAL SUPPORT (CTS) DIRECTED THE CUSTOMER TO ADJUST THE HGB LAMP VOLTAGE, BUT THE HGB BLANK READING WAS 0.0 VOLTS, INDICATING THE HGB LAMP WAS NOT WORKING. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND A LEAK LESS THAN 5 ML FROM THE DRAIN TUBING BELOW THE COMPLETE BLOOD COUNT (CBC) WASTE CHAMBER (VC11) THAT WAS CONTAINED WITHIN THE INSTRUMENT. THE FSE NOTED ERRATIC RED BLOOD CELL (RBC) RECOVERY ON CONTROLS WAS OBSERVED AS THE LEAK ALSO COMPROMISED THE VACUUM IN THE WASTE CHAMBER WHICH IMPACTED DRAINING OF THE RBC BATH THEREFORE IMPACTING THE RBC COUNT. THE FSE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT WHEN THE LEAK WAS DISCOVERED. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382477 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1