BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 10952708 · Received December 5, 2020

    Report

    Report Number
    3002637618-2020-00070
    Event Type
    Death
    Date Received
    December 5, 2020
    Date of Event
    November 11, 2020
    Report Date
    December 30, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS CONDUCTED AN INVESTIGATION INTO THE RAPIDPOINT 500 ANALYZER (S/N (B)(4)) THAT WAS IN USE AT THE TIME OF THIS INCIDENT AND CONCLUDED THE FOLLOWING: A REVIEW OF THE AVAILABLE DATA INDICATES THE RP500 S/N (B)(4) LACTATE SENSOR ON MCART (B)(4) WAS EXPERIENCING INSTABILITY DURING THE TIME PERIOD WHEN THE ESCALATED SAMPLES WERE MEASURED. DEFINITIVE ROOT-CAUSE FOR THE INSTABILITY CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION. AN ENGINEERING SERVICE CALL HAD OCCURRED ON 11NOV2020 APPROXIMATELY 75 MINUTES PRIOR TO THE ESCALATED PATIENT SAMPLES MEASUREMENTS. THIS SERVICE CALL INCLUDED UPGRADING SOFTWARE, CHECKING M-VALVE ALIGNMENT, PERFORMING DIAGNOSTIC CHECKS AND CORRECTLY SEATING THE SAMPLE LUER (WHICH WAS FOUND TO BE IMPROPERLY FITTED). THE MCART WAS RE-INITIALIZED AT THE END OF THE SERVICE. THE ESCALATED PATIENT SAMPLES OCCURRED DURING RETRO-CALIBRATION PERIOD DIRECTLY AFTER THE MCART RE-INITIALIZATION. THE LACTATE SENSOR PRESENTED PERIODIC INSTABILITY, WITH D2 LACTATE CALIBRATION DRIFTS OCCURRING ON THE ESCALATED SAMPLE'S POST-RUN CALIBRATION RESULTING IN THE SAMPLE LACTATE RESULTS BEING FLAGGED AS 'QUESTIONABLE'. ADDITIONALLY IT WAS OBSERVED THAT FOR THE ESCALATED SAMPLES, THE LACTATE INACTIVE SIGNAL WAS HIGH COMPARED TO THE ACTIVE SIGNAL SUGGESTING AN ELEVATED LEVEL OF BACKGROUND NOISE. BY DESIGN THE SYSTEM WILL NOT PROVIDE VALUES FOR PARAMETERS WHICH ARE DRIFTY AND/OR POTENTIALLY SUSPECT. THE .R1 FILES WERE NOT AVAILABLE FROM THE CUSTOMER THEREFORE INDIVIDUAL PATIENT SAMPLE RAW RESPONSE CURVES CAN NOT BE EVALUATED. A DEEPER DIVE INTO THE LACTATE SENSOR DATA DURING THE TIME OF THE ESCALATED SAMPLES SHOWS THE INACTIVE SIGNAL IS HIGH RELATIVE TO THE ACTIVE SIGNAL (~ 1/3 OF THE ACTIVE SIGNAL). ADDITIONALLY THE CALIBRATION DRIFTS ARE HIGH, PROMPTING INITIAL D2 LACTATE CALIBRATION DRIFTS IN THE POST-RUN RETRO-CALIBARATION. A REPEAT CALIBRATION OCCURRED WHICH THEN PASSED. THE CUSTOMER MAY NOT HAVE NOTED THE INITIAL CALIBRATION FAILURE WHICH WAS SUGGESTING SENSOR INSTABILITY. IN ADDITION, THE SYSTEM DETECTED MANY SODIUM INTERFERENCE EXPOSURES SUGGESTIVE OF QUATERNARY AMMONIUM COMPOUND (QAC) EXPOSURES. THIRTEEN SODIUM SENSOR INTERFERENCE DETECTED FLAGS WERE POSTED, AND REAGENT DISTURBANCES IN THE NA+ SENSOR REAGENT RESPONSE CURVE SUPPORTS THIS. QAC ARE KNOWN TO BE NA+ SENSOR INTERFERENCES AND DEPENDING ON THE MAGNITUDE AND TYPE, MAY MOMENTARILY AFFECT THE PERFORMANCE OF OTHER SENSORS AS WELL. A REVIEW OF SKIN PREPARATION AND EXTERIOR INSTRUMENT AND SAMPLING DEVICE CLEANING PRODUCTS WOULD BE ENCOURAGED. SEVERAL D39 OBSTRUCTION ERRORS WERE ALSO SEEN. THIS IS NOT UNUSUAL FOR CAPILLARY SAMPLES TAKEN BY HEEL STICK DUE TO THE CHALLENGE OF COLLECTION. SEVERAL FLUIDIC ERRORS (D23S) WERE ASSOCIATED WITH THE D39 OCCURRENCES. AS THE ENGINEER NOTED, THE SAMPLE LUER WAS FOUND TO BE INCOMPLETELY FITTED WHICH MAY HAVE OCCURRED WHEN AN OPERATOR REPLACED THE SAMPLE LUER AS INSTRUCTED FOLLOWING A D39 OBSTRUCTION. LACTATE MEASUREMENTS ARE PART OF STANDARD SEPSIS PROTOCOLS TOGETHER WITH OTHER LABORATORY TESTS SUCH AS PROCALCITONIN AND WHITE BLOOD CELL COUNT AND OTHER PATIENT'S SYMPTOMOLOGY. BASED ON THE COMPLAINT AND AVAILABLE INFORMATION, THE CUSTOMER IS NOT ALLEGING THAT THE PATIENT WAS INCORRECTLY TREATED OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. THE CAUSE OR DATE OF DEATH WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER STATES THE INSTRUMENT IS OPERATIONAL. THIS MDR IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE INFORMATION FROM THE CUSTOMER STATING THAT THE PATIENT IS DECEASED.

    Additional Manufacturer Narrative · 1

    AN INVASIVE SERVICE CALL WAS CARRIED OUT BY SIEMENS AND THE DIAGNOSTIC AND ALIGNMENT CHECKS PASSED. THE TRACE AND SENSOR FILES WERE EXTRACTED AND SENT FOR INVESTIGATION. THERE WAS NO VISIBLE EVIDENCE OF CONTAMINANTS IN THE AREA BUT THE SYSTEM HAD LOGGED SEVERAL RECENT SODIUM INTERFERENCE EVENTS. SEVERAL OBSTRUCTION ERRORS WERE LOGGED ALSO. THE SAMPLE PORT WAS INCORRECTLY FITTED BY THE LAST OPERATOR TO CHANGE IT. THE SAMPLE PORT WAS REPLACED. IT WAS DISCUSSED WITH THE POC TEAM TO REMIND THE WARD ABOUT PREVENTING CHEMICAL CONTAMINATION. SERVICE RAN THREE LEVELS OF AQC AND CALIBRATION. NO ISSUES WERE FOUND. THIS MDR IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE INFORMATION FROM THE CUSTOMER STATING THAT THE PATIENT IS DECEASED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT LACTATE RESULTS BETWEEN TWO RP 500 INSTRUMENTS. THREE WEEKS LATER, THE CUSTOMER INFORMED SIEMENS THAT THE PATIENT IS DECEASED. SAFETY DATA INFORMATION FROM THE COMPLAINT STATES THAT THE CUSTOMER IS NOT ALLEGING THAT THE CAUSE WAS RELATED TO AN INSTRUMENT MALFUNCTION OR HARM TO THE PATIENT WAS DUE TO THE USE OF THE DEVICE. THE CUSTOMER DOES STATE THAT DUE TO THE DELAY IN TEST RESULTS, THERE WAS A DELAY IN THE START OF ADMINISTERING FRESH FROZEN PLASMA TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416192 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA