BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3903609 · Received June 30, 2014

    Report

    Report Number
    1061932-2014-01499
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 AND REPLACED BROKEN PINCH VALVE (PV37) TUBING TO RESOLVE THE ISSUE. THE FSE ALSO OBSERVED THE INSTRUMENT WAS GENERATING ROCKER BED WILL NOT ROCK ERRORS, CASSETTE LOAD FAILURES AND DOWNLOAD NOT SUCCESSFUL ERRORS DURING STARTUP. IN TROUBLESHOOTING, THE FSE OBSERVED THE RIBBON CABLE FROM THE SAMPLE HANDLER CARD TO THE BACK OF THE ROCKER BED CONTROL (INTERFACE) CARD WAS SLIGHTLY UNPLUGGED ON THE ROCKER BED CONTROL CARD AND SNAPPED IT INTO PLACE (SECURELY ATTACHED) AND THE DOWNLOAD ERRORS WERE RESOLVED. THE FSE THEN REPLACED THE LINKAGE ASSEMBLY ON THE ROCKER BED AND MADE ADJUSTMENTS TO RESOLVE THE ROCKER BED ERRORS AND CASSETTE LOAD FAILURES. THE FSE VERIFIED THE 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 STARTUP. THE VOLUME OF THE LEAK IS UNKNOWN. THE OPERATOR WAS WEARING GLOVES, GOGGLES, AND GOWN AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379560 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1