BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 18143301 · Received November 15, 2023

    Report

    Report Number
    3002637618-2023-00096
    Event Type
    Death
    Date Received
    November 15, 2023
    Date of Event
    May 8, 2022
    Report Date
    December 7, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS CLARIFIED THAT THEIR INQUIRY WAS NOT AN ALLEGATION THAT THE PATIENT DEATH WAS CAUSED BY THE RP500 INSTRUMENT. IN PREPARATION FOR A MEETING WITH THE FAMILY OF THE DECEASED PATIENT, THE NURSE HAD REQUESTED THAT THE LAB MANAGER CONFIRM THAT ALL THE PATIENT TESTS HAD RUN AS EXPECTED. CUSTOMER HAS CONFIRMED THE DATE OF THE EVENT WAS MAY 8, 2022. THE TIMING OF THEIR INQUIRY WAS DUE TO THE MEETING WITH THE FAMILY.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION. THE PH SENSOR IN QUESTION WAS REVIEWED AND FOUND NO SYSTEMIC OR SENSOR-RELATED ERRORS IN AND AROUND THE DATE THE CUSTOMER REQUESTED. MAY 8TH WAS THE ONLY DAY DURING THE INQUIRED TIME PERIOD WHEN PATIENT SAMPLES WERE MEASURED. THE INSTRUMENT ACCURATELY IDENTIFIED AND REPORTED FIVE VALUES, THREE OF WHICH EXCEEDED THE PREDEFINED OPERATIONAL RANGE. THE SAMPLES IN QUESTION APPEAR TO HAVE A TYPICAL PH SENSOR RESPONSE. THERE IS NO EVIDENCE TO SUGGEST ANY SYSTEM OR SENSOR MALFUNCTION. A ROOT CAUSE FOR THE ALLEGED DISCREPANCY CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THE RP500 INSTRUMENT WAS PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INSTRUMENT LOG FILES AND QUALITY CONTROL LIST. SIEMENS REQUESTED INSTRUMENT SENSOR FILES HOWEVER THE CUSTOMER HAS NOT YET PROVIDED THIS. SIEMENS HAS REQUESTED FURTHER INFORMATION ON THE EVENTS LEADING TO THE PATIENT DEATH. AT THIS TIME THE CUSTOMER HAS NOT ALLEGED THAT THERE WAS ANY INSTRUMENT MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. SIEMENS WILL REVIEW THE INSTRUMENT DATA PROVIDED BY THE CUSTOMER. INVESTIGATION IS UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN. THERE IS NO INDICATION THAT THE INSTRUMENT IS NOT OPERATING AS INTENDED.

    Description of Event or Problem · 0

    THE CUSTOMER INDICATED A PATIENT DEATH OCCURRED IN (B)(6) OF 2022. THERE IS NO ALLEGATION THAT THE INSTRUMENT CAUSED OF CONTRIBUTED TO THE DEATH. AT THIS TIME, THERE IS NO ALLEGATION OF DISCREPANT RESULTS OR A PRODUCT MALFUNCTION. THE CUSTOMER HAS REQUESTED AN INVESTIGATION INTO THE INSTRUMENT LOG FILES AND QC RESULTS TO AID IN THEIR OWN INVESTIGATION OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911610 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death