BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4092504 · Received September 16, 2014

    Report

    Report Number
    1061932-2014-02343
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 CONFIRMED THE LEAK FROM DISCONNECTED TUBING AT DILUENT SUPPLY CHAMBER TO SWEEP FLOW. THE FSE RE-CONNECTED THE TUBING WITH A RESTRICTOR TO SLEEVE TO RESOLVE THE LEAK ISSUE AND VACUUM ERRORS. THE FSE ALSO OBSERVED THE LEAK WET THE PELTIER CONNECTORS. THE FSE DRIED THE CONNECTION, RESOLVING THE AMBIENT TEMPERATURE AND +12 VDC ERRORS. THE FSE THEN PERFORMED VERIFICATION OF INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEANER LEAKED FROM THE COULTER LH 500 HEMATOLOGY ANALYZER ONTO THE COUNTER WHILE PERFORMING A SYSTEM TEST. THE VOLUME OF THE LEAK IS UNKNOWN. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED THE INSTRUMENT GENERATED "VACUUM OUT OF RANGE", "AMBIENT TEMPERATURE" AND "+12 VDC OUT OF RANGE" ERRORS DURING THE EVENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573489 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1