BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3200794 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01359
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 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
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND A LEAK AT THE PINCH VALVE VL61. THE FSE REPLACED THE I-BEAM TUBING AT THE VL61 THAT FIXED THE LEAK. WHILE ON SITE, THE FSE OBSERVED PELTIER TEMPERATURE OUT OF LIMIT ERROR. UPON FURTHER INSPECTION, THE FSE DISCOVERED A DEFECTIVE PELTIER MODULE. THE FSE REPLACED THE PELTIER MODULE AND CABLE THAT FIXED THE PELTIER TEMPERATURE OUT OF LIMITS ERROR. FAILURE MODE WAS ATTRIBUTED TO THE LEAK IN TUBING AT VL61. HOWEVER, THE INSTRUMENT GENERATED A PELTIER TEMPERATURE ERROR (THAT WAS MISSED BY THE OPERATOR) TO ALERT THE OPERATOR TO AN INSTRUMENT PROBLEM (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEY WERE GETTING A PUDDLE OF CLENZ LEAKING FROM THE BACK OF THE COULTER LH 750 HEMATOLOGY ANALYZER DURING A START UP. THE VOLUME OF THE LEAK WAS 25 ML AND WAS NOT CONTAINED WITHIN THE ANALYZER. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT OR BIOHAZARD EXPOSURE TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301691 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1