BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3230407 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01415
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED DRIED UP EVIDENCE OF A LEAK OF DILUENT MIXED WITH DEBRIS FROM UNDER INSTRUMENT ONTO COUNTER, UNDER RIGHT HAND SIDE OF THE INSTRUMENT. THE FSE CLEANED UP THE LEAK WHAT APPEARED TO BE LESS THAN 5-10 ML OF LIQUID. THE FSE ISOLATED THE LEAK TO A LOOSE FITTING ENCLOSED WITHIN TRIPLE TRANSDUCER MODULE (TTM) AT QUICK DISCONNECT 9-3 (QD9-3). THE FSE RE-DRESSED ALL TUBING AND ENSURED ALL FITTINGS SERVICING THE QD9-3 WERE SECURE AND LEAK FREE. THE FSE PERFORMED VERIFICATION AND CHECKED THE TTM AGAIN PRIOR TO LEAVING; NO FURTHER LEAKS WERE OBSERVED. FAILURE MODE OF THE LEAK WAS RELATED TO THE LOOSE FITTING ON QD9-3. BECKMAN INTERNAL IDENTIFIER NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT AN UNKNOWN AMOUNT OF BROWN LIQUID HAD LEAKED IN THE BOTTOM OF THE COULTER LH 780 HEMATOLOGY ANALYZER AND ONTO THE COUNTER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327964 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1