BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3222827 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01447
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE OBSERVED DILUENT LEAKING OUT OF THE RIGHT SIDE OF THE INSTRUMENT. THE FSE REPLACED TUBING FROM THE BACKWASH TANK (VC23), RESOLVING THE BACKWASH TANK NOT FULL ERRORS AND TUBING THAT HAD POPPED OFF OF THE DIFFERENTIAL PUMP (PM1 OR PM4), RESOLVING THE LEAK ISSUE. THE FSE STATED THAT BOTH TUBINGS WERE DRIED OUT, CRACKED (WORN) AND LEAKING. FAILURE MODE WAS ATTRIBUTED TO THE BACKWASH TANK (VC23) TUBING AND THE DIFFERENTIAL PUMP TUBING; HOWEVER, THE INSTRUMENT GENERATED BACKWASH TANK NOT FULL ERRORS ALERTING CUSTOMER TO AN INSTRUMENT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT AN UNKNOWN AMOUNT OF FLUID THAT APPEARED TO BE DILUENT LEAKED FROM THE COULTER LH 750 HEMATOLOGY ANALYZER ON THE RIGHT HAND SIDE OF THE UNIT, WHICH WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER OBSERVED THE LEAK WHEN THEY ATTEMPTED TO START RUNNING PATIENT SAMPLES AFTER RECEIVING A BACKWASH TANK NOT FULL ERRORS. THE CUSTOMER INDICATED THAT THEY HAD RUN QUALITY CONTROL (QC), WITH NO ISSUES AND THERE WERE NO ERRORS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THIS EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS INCIDENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324322 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1