BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4092481 · Received September 16, 2014

    Report

    Report Number
    1061932-2014-02334
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OBSERVED A HOLE IN THE TUBING THROUGH PINCH VALVE (PV37) WHICH CAUSED THE CLEANER TO LEAK. THE FSE REPLACED THE TUBING THROUGH PINCH VALVE (PV37) AND THE INSTRUMENT PERFORMED WITHOUT ANY LEAKS. THE FSE OBSERVED THE LEAK HAD DAMAGED THE CONNECTOR FOR THE PELTIER MODULE. THE FSE CLEANED THE CONNECTOR FOR THE PELTIER MODULE AND THE INSTRUMENT PERFORMED WITHOUT ANY "TEMPERATURE" ERRORS. THE FSE ALSO OBSERVED THE TUBING HAD DISCONNECTED FROM THE VACUUM REGULATOR. THE FSE RE-ATTACHED THE TUBING AND THE INSTRUMENT PERFORMED WITHOUT ANY "VACUUM" ERRORS. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSTRUMENT GENERATED "LOW VACUUM" ERROR AND APPROXIMATELY 4 MLS OF CLEANER LEAKED FROM THE COULTER LH 500 HEMATOLOGY ANALYZER ONTO THE COUNTER WHILE PERFORMING STARTUP. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, EYE GLASSES 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
    572934 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1