BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3972121 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01775
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE COULD NOT DETERMINE WHICH TUBING AROUND THE DIFFERENTIAL MIXING CHAMBER (MC1) WAS LEAKING; ALL TUBINGS WERE REPLACED TO RESOLVE THE LEAK ISSUE. THE FSE ALSO OBSERVED THE DIFFERENTIAL MIXING MOTOR (MC1) WAS NOT FUNCTIONING DUE TO THE LEAK. THE FSE REPLACED THE MIXING MOTOR WHICH RESOLVED THE LOW VACUUM AND NO DIFFERENTIAL RESULTS. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN 20 MLS OF CLEAR FLUID LEAKED FROM THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER ONTO THE COUNTERTOP WHILE TROUBLESHOOTING. THE CUSTOMER STATED THAT LOW VACUUM (VAC) ERRORS AND DIFFERENTIAL (DIFF) RESULTS WERE GENERATED (INCOMPLETE OR ABNORMAL COMPUTATION) WHILE PERFORMING CONTROLS. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, PERSONAL EYE PROTECTION, AND A LAB COAT AT THE TIME OF THE OCCURRENCE. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OF AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447800 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1