BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3840020 · Received May 30, 2014

    Report

    Report Number
    1061932-2014-01131
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    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 FOUND A LEAK FROM COMPLETE BLOOD COUNT (CBC) LYSE RESTRICTOR TUBING DUE TO SMALL PIN HOLE AT FITTING SIDE OF THE TUBING. THE FSE REPLACED TUBING AND PERFORMED CBC LYSE PRIME AND VERIFIED NO FURTHER LEAKING. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERNAL/EXTERNAL LEAKING AT THE RIGHT SIDE OF THE COULTER LH 750 HEMATOLOGY ANALYZER WHILE RUNNING SAMPLES. THE VOLUME OF THE LEAK WAS APPROXIMATELY 5 ML OF CLEAR FLUID. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER WAS WEARING GLOVES AND LAB COAT AT THE TIME OF THE INCIDENT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. 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
    319070 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1