BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3942667 · Received July 17, 2014

    Report

    Report Number
    1061932-2014-01679
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE FLUID LEAKED FROM PINCH VALVE 37 (PV37) ON THE INSTRUMENT. THE FSE REPLACED ALL OF THE TUBING AT PV37 AND RESOLVED THE FLUID LEAK ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE TUBING AT PINCH VALVE PV37. A DEFINITIVE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY THREE (3) MILLILITERS OF BLUE FLUID LEAKED ON THE RIGHT SIDE OF THE INSTRUMENT WHILE PROCESSING LATRON CONTROL INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE FLUID WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PROTECTIVE GLOVES AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AS PATIENT SAMPLES WERE NOT ANALYZED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL AND RISK MANAGEMENT PLAN IN PLACE FOR BIOHAZARD MATERIAL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418172 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1