BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3864512 · Received June 10, 2014

    Report

    Report Number
    1061932-2014-01303
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 AND REPAIRED A CRACKED SHEATH PORT ON THE FLOWCELL. ON (B)(4) 2014, THE FSE REPLACED THE FLOWCELL. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS DESCRIBED AS A FLUID LEAK OF APPROXIMATELY 5-10 ML. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. ERROR CONDITIONS OF "LASER OFFSET TOO HIGH" AND "RF VOLTAGE LOW'" WERE GENERATED DURING THE INSTRUMENT START-UP PROCEDURE. THE OPERATOR WAS WEARING LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF BIOHAZARD 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 PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341393 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1