BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3803311 · Received May 9, 2014

    Report

    Report Number
    1061932-2014-01035
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND A LEAK AT THE FITTING ON THE PELTIER MODULE. THE FSE REPLACED THE TUBING TO REPAIR THE LEAK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS DESCRIBED AS 20 MILLILITER (ML) OF YELLOW LIQUID LEAKED FROM THE INSTRUMENT AND FLOWED ONTO THE COUNTER WHILE THE INSTRUMENT WAS IDLE. NO SYSTEM ERROR MESSAGES GENERATED. THE CUSTOMER WAS WEARING GOWN, GLOVES, AND GOGGLES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280434 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1