BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 14001594 · Received April 4, 2022

    Report

    Report Number
    3002637618-2022-00024
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 28, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS PROVIDED INSTRUMENT LOG FILES FOR FURTHER INVESTIGATION. INVESTIGATION IS UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION OF THE PROVIDED INSTRUMENT LOG FILES. A REVIEW OF THE SYSTEMS DATALOG FOUND OBSTRUCTION ERRORS WHICH ARE CAUSED BY OBSTRUCTIONS IN THE SAMPLE PATH LIKE BLOOD CLOTS. THERE IS ALSO EVIDENCE OF THE SODIUM SENSOR BEING EXPOSED TO INTERFERENTS LIKE QUATERNARY AMMONIUM COMPOUNDS (QAC) OR CHLOROHEXIDINE. THE CUSTOMER IS USING CLINELL WIPES AS A DISINFECTANT AND IT IS KNOWN TO CONTAIN CHLOROHEXIDINE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED MULTIPLE DISCREPANT SODIUM RESULTS ON THEIR RP500E INSTRUMENT ON ONE PATIENT OVER SEVERAL DAYS COMPARED TO REPEAT TESTING OF THE SAME SAMPLES ON NON-SIEMENS BLOOD GAS INSTRUMENTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603389 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female