BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 17558884 · Received August 16, 2023

    Report

    Report Number
    3002637618-2023-00064
    Event Type
    Death
    Date Received
    August 16, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 29, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS PROVIDED INSTRUMENT LOG FILES FOR FURTHER INVESTIGATION. THE CUSTOMER HAS NOT STATED IF THEY BELIEVE THE INSTRUMENT CONTRIBUTED TO THE PATIENT DEATH. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM DATA LOGS FOUND THAT THE COOXIMETRY SUB-UNIT ON THE INSTRUMENT IN QUESTION WAS PERFORMING AS INTENDED. THERE WERE NO RECORDED SYSTEM OR SENSOR RELATED ERRORS/MESSAGES IN AND AROUND THE TIME OF THE ESCALATED SAMPLE. FOR THE SAMPLES IN QUESTION, THE OPTICAL SPECTRUM FAILED TO MEET THE INTERNAL QUALITY REQUIREMENTS FOR WHOLE BLOOD AND THE COOXIMETRY PARAMETERS WERE FLAGGED AS ¿QUESTION RESULT¿. PARAMETERS FLAGGED FOR ATYPICAL RESPONSES ARE NOT REPORTED. THE RP500E SN (B)(6) INSTRUMENT WAS WORKING AS INTENDED AND PER ITS SPECIFICATIONS, IT FLAGGED THE CO-OX RESULTS FOR THIS SAMPLE WITH A QUESTION RESULT FLAG, APPROPRIATELY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A "-----? QV" (QUESTION VALUES) RESULT FOR THB ON A PATIENT WHO HAD TAKEN SODIUM NITRATE. THE PATIENT LATER PASSED AWAY. "-----?" INDICATES THE SYSTEM HAS AN ATYPICAL RESPONSE WHEN MEASURING THIS PARAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458862 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death