BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 18741200 · Received February 20, 2024

    Report

    Report Number
    3002637618-2024-00011
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    February 6, 2024
    Report Date
    April 19, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE REVIEW AND ANALYSIS OF THE PROVIDED DATA FOR THE INSTRUMENT LOG WITH THE MEASUREMENT CARTRIDGE INSTALLED, AQC EXPECTED RECOVERY, RAW SIGNAL RESPONSES, REAGENT RESPONSE CURVES, AND CALIBRATION HISTORY; THE ROOT CAUSE FOR THE LOW NA+ RESULT RECOVERIES FOR THE ESCALATED PATIENT SAMPLES IN QUESTION WERE DUE TO AN UNSTABLE NA+ SENSOR. THE NA+ SENSOR WAS EXPOSED TO QUATERNARY AMMONIUM COMPOUNDS (QAC). THE CUSTOMER CONFIRMED THE USE OF CLINELL WIPES. PER THE CUSTOMER BULLETIN 2020-12 (CUST-00271-EDG): ¿EXTERIOR DISINFECTING CLEANERS FOR THE RAPIDPOINT® 405/500/500E SYSTEMS¿ AND THE RAPIDPOINT 500 OPERATOR¿S GUIDE, ANY CLEANING AGENT THAT CONTAINS BENZALKONIUM OR OTHER QUATERNARY AMMONIUM COMPOUNDS AS AN INGREDIENT SHOULD NOT BE USED AS AN EXTERIOR DISINFECTANT FOR THE RAPIDPOINT 405/500/500E SYSTEMS AND SAMPLING DEVICES USED FOR BLOOD GAS ANALYSIS. THESE SUBSTANCES ARE KNOWN INTERFERENTS TO THE NA+ SENSOR AND CAN DESTABILIZE THE SENSOR, CAUSING CALIBRATION ISSUES, AND SIGNIFICANTLY IMPACTING RESULTS; THEREFORE, SHOULD BE AVOIDED. THE SOURCE CONTAINING QAC SHOULD BE IDENTIFIED AND ELIMINATED. THE RP500 INSTRUMENT IS CURRENTLY OPERATIONAL AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS PROVIDED INSTRUMENT FILES FOR FURTHER INVESTIGATION. AN INITIAL VIEW OF THE FILES PROVIDED SHOW "SODIUM SENSOR INTERFERENT DETECTED" MESSAGES. INVESTIGATION ONGOING TO DETERMINE IF THIS WAS THE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    CUSTOMER ALLEGES DISCREPANT LOW SODIUM RESULT WHEN COMPARED TO RETESTING OF A DIFFERENT SAMPLE ON THE SAME ANALYZER AND ANOTHER RP500 ANALYZER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298567 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown