BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3233527 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01506
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPORTED AN ISSUE WITH TUBING AND RINSE BLOCK TRAVEL. THE FSE REPLACED THE TUBING IN PINCH VALVE PV35, PV36 AND PV42. THE FSE ALSO OBSERVED THE RINSE BLOCK WAS NOT COVERING THE PROBE TIP, WHICH CAUSED THE DILUENT TO LEAK. THE FSE ADJUSTED THE TRAVEL DISTANCE AND PERFORMED SAMPLES WITHOUT ANY LEAKS. SYSTEM MODE-TO-MODE VERIFICATION WAS PERFORMED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THREE DROPS OF DILUENT LEAKED FROM THE RINSE BLOCK, INSIDE THE UNIT, DURING SYSTEM BACKWASH INVOLVING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE OPERATOR WAS WEARING A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FACILITY HAS AN EXPOSURE CONTROL AND RISK MANAGEMENT PLAN IN PLACE FOR BIOHAZARD MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334068 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1