BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2502981 · Received March 26, 2012

    Report

    Report Number
    1061932-2012-01007
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE LEAK IS UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF INSIDE THEIR COULTER LH 500 HEMATOLOGY ANALYZER INSTRUMENT AS WELL AS NOTING ABOUT 2MLS OF LIQUID UNDERNEATH THE INSTRUMENT. THE CUSTOMER ALSO REPEATED THE INSTRUMENT WAS LOCKING UP. THE FLUIDS ASSOCIATED WITH THIS LEAK ARE: LYSE S III, 5C CONTROL, RETIC C CONTROL AND RETIC PAK REAGENT B (STAIN CLEARING SOLUTION). CUSTOMER TECHNICAL SUPPORT, INSTRUCTED THE CUSTOMER TO CYCLE POWER ON THE INSTRUMENT. WHEN THE SYSTEM POWERED UP A LOW VACUUM ERROR WAS GENERATED, THEREFORE, THE CUSTOMER PERFORMED A SYSTEM TEST TO MONITOR VACUUM AND PRESSURE. AT THE CONCLUSION OF THIS TEST, THE CUSTOMER STATED SHE RECEIVED 'VACUUM TRAP FULL' AND 'RBC BATH OVERFLOW MESSAGE'. CTS INSTRUCTED THE CUSTOMER CHECK THE RIGHT SIDE TO SEE IF VACUUM TRAP HAD FLUID AND SHE DISCOVERED LH COULTER CLEANER REAGENT ON THE COUNTER UNDERNEATH THE LH 500 INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. A FIELD SERVICE ENGINEER (FSE) REPORTED INTERMITTENT INSTRUMENT ISSUES. INSTRUMENT LOCKS UP, NOTICEABLY WHEN DILUTING OR PRIMING. SYSTEM DOWNLOAD LOCKS UP WHEN THE UNIT IS TURNED OFF THEN ON. THE FSE REPLACED 376 CPC CD. SERVICE ACTIVITY PERFORMED IS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. SYSTEM VALIDATION DOCUMENTED IN CUSTOMER QC RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1