BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAPIDPOINT 500 BLOOD GAS SYSTEM

    MDR report key: 11665418 · Received April 14, 2021

    Report

    Report Number
    3002637618-2021-00026
    Event Type
    Death
    Date Received
    April 14, 2021
    Date of Event
    March 24, 2021
    Report Date
    May 7, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION: BASED ON THE DATA PRESENTED IN THIS INVESTIGATION, THE CO-OXIMETRY OPTICAL SUBSYSTEM RESPONSIBLE FOR THE MEASUREMENT OF THB APPEARED STABLE AND FUNCTIONING AS EXPECTED. THIS WAS DETERMINED BASED ON THE CO-OX QUALITY CHECKS, PERFORMANCE WITH AQC (THB), LACK OF ANY CO-OX RELATED CALIBRATION DRIFTS OR DIAGNOSTIC ERRORS DURING THE TIME PERIOD OF THE ESCALATED EVENT. THE CO-OX UNIT AND THE SPECTROPHOTOMETERS WERE WORKING AS EXPECTED. THE REPORTED THB IS BASED ON MEASURING THE BLOOD CELLS AS DELIVERED TO THE CO-OX SLIDE CELL. FOR AN ACCURATE MEASUREMENT OF THB, THOROUGH MIXING AND ROTATING OF THE RED BLOOD CELLS IMMEDIATELY BEFORE ANALYSIS IS REQUIRED. A DEFINITE ROOT-CAUSE FOR THE OBSERVED DISCREPANCY IN THB RESULTS BETWEEN SN (B)(6) AND SN (B)(6) COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DATA FILES HAVE BEEN RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE CAUSE OF THE DISCREPANT TOTAL HEMOGLOBIN RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON ONE PATIENT WHEN RUN ON TWO RP 500 INSTRUMENTS. THE CUSTOMER STATED THAT THE PATIENT DIED FROM COVID-19 AFTER ECMO TREATMENT. THE CUSTOMER CONFIRMED THEY ARE NOT ALLEGING THE RP 500 CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT AND THAT THE PATIENT WAS NOT INCORRECTLY TREATED BASED ON THE RP 500 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565458 RAPIDPOINT 500 BLOOD GAS SYSTEM RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR