BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AUTOLOADER ANALYZER (115V)

    MDR report key: 3223199 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01455
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE PERFORMED ROUTINE MAINTENANCE TROUBLESHOOTING ON THE BLOOD SAMPLING VALVE (BSV) AND PROBE WIPE ASSEMBLY AND FOUND THAT A SCREW BEHIND THE AIR CYLINDER WAS MISSING, THUS CAUSING THE PROBE WIPE ASSEMBLY TO BIND UP AND CAUSE DILUENT TO INTERMITTENTLY LEAK OUT. THE FSE REPLACED THE SCREW WHICH STABILIZED THE PROBE WIPE ASSEMBLY AND ELIMINATED THE BINDING UP. NO MORE LEAKING OCCURRED FROM THE PROBE WIPE ASSEMBLY. ISSUE RESOLVED. FAILURE MODE: PROBE WIPE ASSEMBLY. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT 1 ML OF DILUENT LEAKED FROM PROBE OF THE COULTER HMX AUTOLOADER ANALYZER (115V). THE CUSTOMER INDICATED THAT THIS WAS AN ONGOING ISSUE. THE FLUID WAS NOT CONTAINED WITHIN THE UNIT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, GLOVES, AND PROTECTIVE EYEWEAR AT THE TIME OF THE OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324415 COULTER® HMX AUTOLOADER ANALYZER (115V) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER HMX AL 115V NA

    Patients

    Seq Age Sex Outcome Treatment
    1