BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2181872 · Received July 28, 2011

    Report

    Report Number
    1061932-2011-01039
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLEANER LEAK FROM THE PV37 HAD SPRAYED THE PELTIER ASSEMBLY AND SHORTED IT OUT. THE CUSTOMER REPLACED THE TUBING THROUGH NC PV37, PRIMED ALL REAGENTS AND NO FURTHER LEAKS WERE OBSERVED. REVIEW OF PROSERVICE SHOWED LYSE AND AMBIENT TEMP ERRORS. THE CUSTOMER SHUT DOWN THE ANALYZER AND REMOVED P4 FROM PELTIER MODULE. A BEC FIELD SERVICE ENGINEER (FSE) MADE A MINOR ADJUSTMENT TO THE CONDUCTIVITY WHICH REPEATED IN RANGE BEFORE AND AFTER 5C AND PATIENT SAMPLES WERE RUN. FSE RAN STARTUPS, LATRON CONTROLS AND BOTH LOTS OF 5C CONTROLS IN BOTH PRIMARY AND SECONDARY MODES WITHOUT A PROBLEM. THE LYSE AND AMBIENT TEMPERATURE ALARMS DID NOT RETURN. FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ATTRIBUTED TO THE TUBING WHICH WAS WORN BY THE ACTION OF PV37. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT ALH500 INSTRUMENT CLEANER LEAK FROM THE TUBING IN NORMALLY CLOSED (MC) PINCH VALVE (PV) 37 BETWEEN FEED-THRU FITTING (FF) 107 AND FF 124. CUSTOMER TECHNICAL SERVICE (CTS) GUIDED THE CUSTOMER THROUGH SUCCESSFUL RESOLUTION OF THE LEAK; HOWEVER A REVIEW OF PROSERVICE SHOWED LYSE AND AMBIENT TEMPERATURE ERRORS. CLEANER WAS FOUND IN THE PELTIER MODULE AND A SERVICE CHECK WAS REQUESTED. THE OPERATOR WAS WEARING A LAB COAT, GLOVES, AND SAFETY GOGGLES AT THE TIME OF OCCURRENCE. NO INJURIES OR EXPOSURE TO SKIN, OPEN WOUNDS OR MUCOUS MEMBRANES WERE REPORTED. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO DEATH OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1