BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 4185158 · Received October 17, 2014

    Report

    Report Number
    3002807968-2014-00046
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    PMA / PMN Number
    K093154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS INTENDED ONLY AS AN ADJUNCT IN PATIENT ASSESSMENT AND MUST BE USED IN CONJUNCTION WITH CLINICAL SIGNS AND SYMPTOMS (OPERATORS MANUAL PAGE 1-2). IT CAN THUS NOT BE EXPECTED THAT RESULTS FROM THE TCM ANALYZER MATCHES RESULTS FROM A BLOOD SAMPLE. THIS EVENT IS SUSPECTED TO BE CAUSED BY A USER ERROR SINCE THE USER USED CONTACT GEL INSTEAD OF ELECTROLYTE SOLUTION DURING RE-MEMBRANING. THIS RISK WAS ANTICIPATED IN THE PRODUCT RISK ANALYSIS AND HAS BEEN MITIGATED BY COLOR CODING OF SENSORS AND SUPPLIES (THE ELECTROLYTE SOLUTION AND CONTACT GEL HAS DIFFERENT COLORED LABELS AND TOPS) AND BY NOTIFICATION OF THE USER IN A GUIDE WHICH DESCRIBE THE COLOR CODE AND USE OF RIGHT SUPPLIES. WHILE THE RADIOMETER REPRESENTATIVE VISITED THE CUSTOMER WITH CORRECT USE OF THESE SUPPLIES WAS EXPLAINED. THE SENSOR IN QUESTION HAS BEEN INVESTIGATED, AND THE INVESTIGATION SHOWED THAT THE SENSOR HAD A TOO HIGH RESPONSE TIME. THIS IS SUSPECTED TO BE DUE TO THE INCORRECT USE OF SUPPLIES WITH THIS SENSOR. THIS IS CURRENTLY BEING CONFIRMED. THIS EVENT IS CONSIDERED TO BE A REPORTABLE USER ERROR AND SINCE NO PRODUCT MALFUNCTION HAS BEEN ESTABLISHED OR IS SUSPECTED, THIS EVENT IS REPORTED AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED RADIOMETER DUE TO A PROBLEM WITH THE TCPCO2 SENSOR. WAS 5, 2 AN THE BLOOD SAMPLE WAS 15,4. THE RADIOMETER REPRESENTATIVE RE-MEMBRANED THE SENSOR AND THEN TCPCO2 SENSOR SHOWED 11, 3 AND A BLOOD GAS SAMPLE WAS 10, 7. THE NEXT DAY THE CUSTOMER USED THE SENSOR FOR SOME HOURS AND THEN SUDDENLY THE TCPCO2 SENSOR STOPPED WORKING. DURING THE RE-MEMBRANING OF THE SENSOR, PERFORMED BY THE RADIOMETER REPRESENTATIVE IT WAS DISCOVERED THAT THE CUSTOMER, BY MISTAKE, HAD USED CONTACT GEL INSTEAD OF ELECTROLYTE SOLUTION WHILE PERFORMING THE RE-MEMBRANING OF THE SENSOR. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660596 TRANSCUTANEOUS BLOOD GAS MONITOR TCM 4 TOSCA COMBI M LKD RADIOMETER MEDICAL APS TOSCA 92 SENSOR 9234613

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other