BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3183324 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01228
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND THAT THE NEEDLE BELLOWS DRAIN (VL57A) WAS STICKING CAUSING THE LEAK. THE FSE REPLACED THE VL57A WHICH RESOLVED THE LEAK. THE FSE ALSO DISCOVERED THAT THE INSTRUMENT WAS GIVING RETIC VOTE OUTS AS A RESULT OF A MALFUNCTIONING BLOOD/STAIN ASPIRATION PUMP (PM11). THE FSE REPLACED THE PM11 AS WELL AS REPLACED ALL ASSOCIATED TUBING IN THE RETIC AREA AND THE SHEATH TANK AS PREVENTATIVE MAINTENANCE. THE RETIC ISSUE WAS NOT ASSOCIATED WITH THE LEAK REPORTED BY THE CUSTOMER. 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 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 WHILE RUNNING CONTROLS APPROXIMATELY LESS THAN 10 MLS OF BLOOD HAD LEAKED INSIDE THE NEEDLE BELLOWS OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR AT THE TIME OF THE INCIDENT. 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 THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283111 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1