BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL 800 FLEX

    MDR report key: 2192726 · Received July 6, 2011

    Report

    Report Number
    3002807968-2011-00011
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 13, 2011
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K051968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER CLEANED THE ANALYZERS FLUIDIC PATH AND PERFORMED THOROUGH MAINTENANCE. DATA LOGS FROM THE INSTRUMENT WERE ANALYZED. THE ERROR WAS CAUSED BY A CLOT INTRODUCED WITH THE SAMPLE AT 17:30, AND AFFECTED PH AND THE REFERENCE DEPENDENT ELECTROLYTES (K+, NA+, CA++, AND CL-). THE LAST QC WAS PERFORMED 07:41 IN THE MORNING, AND WAS OK. THE LAST CALIBRATION WAS PERFORMED 16:03 AND WAS OK. THE ERROR WAS DETECTED WITH THE FOLLOWING QC AT 18:59, AND ALL FOLLOWING QC RESULTS WERE MARKED WITH ERRORS FOR PH, K+, NA+, CA++, AND CL-. THE OPERATORS MANUAL STATES THE FOLLOWING WARNING (P.12-2; 'SAMPLING DEVICES AND PROCEDURES'): 'WARNING - RISK OF ERRONEOUS RESULTS. ALWAYS METICULOUSLY FOLLOW THE SAMPLING PROCEDURES DESCRIBED IN THIS CHAPTER. FAILURE TO FOLLOW THESE PROCEDURES MAY INTRODUCE CLOTS OR AIR BUBBLES IN THE SAMPLE AND YIELD ERRONEOUS RESULTS.'

    Description of Event or Problem · 1

    ONE PT SAMPLE ANALYZED (B)(6) 2011, 17:30 YIELDED PH 6,89, POTASSIUM 11,5 MMOL/L, CHLORIDE 11 MMOL/L. A COMPARISON MEASUREMENT FROM ANOTHER INSTRUMENT PERFORMED ONE HOUR LATER YIELDED PH 7,38, POTASSIUM 3,6 MMOL/L, CHLORIDE 109 MMOL/L. AS QC AND CALIBRATION RESULTS WERE OK, THE ANALYZER'S STATUS LIGHT WAS GREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL 800 FLEX BLOOD GAS ANALYZER CHL RADIOMETER MEDICAL APS ABL 835

    Patients

    Seq Age Sex Outcome Treatment
    1