BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL800 FLEX

    MDR report key: 2192755 · Received June 14, 2011

    Report

    Report Number
    3002807968-2011-00010
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    PMA / PMN Number
    K051968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA LOGS FROM THE REGARDED INSTRUMENT WAS ANALYZED. THE ISSUE WAS CAUSED BY A CLOT ON THE PH ELECTRODE AND THIS WILL HAVE AFFECTED THE RESULTS ON THE REF PARAMETERS AS IT IS LOCATED BETWEEN THE REF AND NA+/K+ ELECTRODES. THE REGARDED PT WAS (B)(6), TESTED AT 14:47. MEASUREMENT #33014 (14:36) WAS MARKED WITH '(476) - MEASUREMENT UNSTABLE' DUE TO THE CLOT IN THE PH ELECTRODE CHAMBER. THE LATEST QC WAS PERFORMED AT 8:00 IN THE MORNING, AND PASSED. THE LATEST CALIBRATION WAS A 1 POINT CAL. ON 12:30, WHICH PASSED. CALIBRATIONS AFTER INTRODUCTION OF THE CLOT FAILED AT 15:51, 16:04 AND 16:32. THE CLOT WAS FINALLY FLUSHED OUT, AND THE FOLLOWING CALIBRATION PASSED AT 16:41. 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.' THE ANALYZER SOFTWARE CONTAINS A CLOT DETECTION FEATURE, WHICH EVALUATES THE QUALITY OF THE SAMPLE AND EFFECTIVELY DETECTS CLOTS. THE CUSTOMER CONSIDERS ENABLING THE PH CLOT DETECTION DUE TO THE FACT THAT ALL OPERATORS MAY NOT CARRY OUT VISUAL INSPECTION OF CLOTS. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    FIVE PT SAMPLES WERE ANALYZED, THE RESULTS PRODUCED FOR NA+ AND K+ WERE INCORRECT. THE LAST CALIBRATION AND QC HAD PASSED AND NO ERROR MESSAGES WERE PRESENT ON PT RESULT REPORTS. PROBLEM WAS IDENTIFIED BY STAFF AS SODIUM LEVELS ON ONE OF THE PTS WAS 110 MMOL/L ON BLOOD GAS ANALYZER AND 139 MMOL/L ON LAB ANALYZER. POTASSIUM RESULTS WERE ALSO LOW (2.4-2.9 MMOL/L). POTASSIUM SOLUTION WAS READY TO ADMINISTER BUT THEY WAITED FOR LAB RESULTS SO IT WAS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL800 FLEX BLOODGAS ANALYZER CHL RADIOMETER MEDICAL APS ABL800 FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1