BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 8213400 · Received January 3, 2019

    Report

    Report Number
    3002637618-2019-00002
    Event Type
    Death
    Date Received
    January 3, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 3, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    UDI-DI
    00630414589169
    PMA / PMN Number
    K122539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REVIEWED THE DATA FILES PROVIDED BY THE CUSTOMER. THE K+ SENSOR ON RP500 SN (B)(4), CARTRIDGE SN (B)(4) WAS PERFORMING AS INTENDED WITH NO SYSTEM ERRORS OR DISTURBANCES AROUND THE TIME THE SUSPECT SAMPLE WAS RUN. REPEAT ANALYSIS OF THE SAME SAMPLE PROVIDED SIMILAR K+ RESULTS ON AN ALTERNATE ANALYZER. THE CUSTOMER STATED THAT THERE WAS NO EVIDENCE OF HEMOLYSIS. THE CUSTOMER IS NOT ALLEGING THAT THE RP 500 RESULT WAS INCORRECT. THE CARTRIDGE IS STILL INSTALLED ON THE INSTRUMENT AND IS OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISCREPANT POTASSIUM RESULT RUN ON THE RP 500 S/N (B)(4) WHEN COMPARED TO RESULTS ON A NON-SIEMENS LAB ANALYZER, ON A CODE PATIENT WHO CAME INTO THE MEDICAL CENTER. THE PATIENT HAS KIDNEY FAILURE BUT HAD NOT RECEIVED DIALYSIS AND THEY WERE EXPECTING HYPERKALEMIA. THE PATIENT WAS GIVEN CALCIUM FOR CARDIAC SUPPORT. A SAMPLE WAS DRAWN FROM A LINE INTO A LITHIUM HEPARIN VACUUM TUBE AND WAS RUN ON THE NON-SIEMENS LAB ANALYZER AT 10:25. THE PATIENT WAS GIVEN INSULIN AND ALBUTEROL. A FEMORAL ARTERY SAMPLE WAS RUN ON THE RP 500 AT 10:38. THIS SAME FEMORAL ARTERY SAMPLE WAS RUN ON THE NON-SIEMENS LAB ANALYZER AT 14:40. THE CUSTOMER WAS ASKED IF AN ADDITIONAL SAMPLE WAS DRAWN FROM THE PATIENT AND SHE STATED THAT NO ADDITIONAL BLOOD WAS DRAWN BECAUSE THE PATIENT HAD DIED. THERE IS NO ALLEGED HARM TO THE PATIENT OR USER DUE TO THE USE OF THE RP 500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5326 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS 00630414589169

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death