BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 16280127 · Received February 1, 2023

    Report

    Report Number
    3002637618-2023-00004
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 21, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION. BASED ON SYSTEM'S SUMMARY LOGS, AFTER DETECTION OF EXCESSIVE NA+ INTERFERENCE AND REPLACING EXPIRED WASH/WASTE CARTRIDGE, THE NA+ SENSOR WAS DISABLED BY RP500 SYSTEM FOR TWO CONSECUTIVE PERIODS AND SEVERAL FULL CALIBRATIONS WERE PERFORMED BY SYSTEM TO RETRIEVE THE NORMAL PERFORMANCE. THE SODIUM SENSOR WAS IN RECOVERY PROCESS WHEN IT WAS IMPACTED FOR THE SECOND TIME BY ANOTHER QAC EXPOSURE. PER THE INSTRUMENT MANUAL, THE USER IS INSTRUCTED NOT TO USE ANY SKIN DISINFECTING PRODUCTS AND/OR EXTERIOR DISINFECTANTS THAT CONTAIN QUATERNARY AMMONIUM COMPOUNDS (QAC) AS THEY ARE KNOWN INTERFERENTS TO THE RP500/500E NA+ SENSOR BY POTENTIALLY IMPACTING THE SENSOR AND ITS' PERFORMANCE AND SHOULD BE AVOIDED. THE SOURCE CONTAINING QAC SHOULD BE IDENTIFIED AND ELIMINATED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THAT THE DEVICE HAD A SODIUM INTERFERENCE. CUSTOMER FACING DOCUMENTATION ADVISES THE CUSTOMER NOT TO USE INTERFERING SUBSTANCES WHICH CAN CAUSE A SPIKE IN SODIUM RESULTS. THE CUSTOMER HAS BEEN ADVISED TO REPLACE THE MEASUREMENT CARTRIDGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR INSTRUMENT GAVE A DISCREPANT HIGH SODIUM RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376433 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown