BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3191564 · Received June 26, 2013

    Report

    Report Number
    1061932-2013-01195
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND CONFIRMED THAT THE PROBE RINSE BLOCK WAS LEAKING INTERMITTENTLY DURING THE RINSE CYCLE. THE FSE ALIGNED THE PROBE RINSE BLOCK AND REPLACED THE TUBING THROUGH VALVE PV49, RESOLVING THE LEAK. THE FAILURE MODE WAS RELATED TO A MISALIGNED PROBE RINSE BLOCK AND TO PINCHED TUBING AT VALVE PV49. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A 1-2 ML BLOODY FLUID LEAK FROM THE MANUAL PROBE OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK OCCURRED DURING THE RINSE CYCLE AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291744 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1