BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 24831895 · Received April 9, 2026

    Report

    Report Number
    3002637618-2026-00029
    Event Type
    Death
    Date Received
    April 9, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 9, 2026
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    00809708016685
    PMA / PMN Number
    K200107
    Removal / Correction Number
    3002637618-04-02-2026-00
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHINEERS HAS CONFIRMED THE OCCURRENCE OF DISCREPANT LOW PH AND MEASURED TOTAL CARBON DIOXIDE (MTCO2) RESULTS IN ARTERIAL, VENOUS, AND CAPILLARY PATIENT SAMPLES. A FIELD ACTION WAS INITIATED FOR THE AFFECTED TEST CARDS. A PROXIMATE ROOT CAUSE HAS BEEN LINKED TO MANUFACTURING LIMITED TO ONE BATCH OF RAW MATERIAL USED IN THESE AFFECTED LOTS. THIS EVENT OCCURRED PRIOR TO THE INITIATION OF THE FIELD ACTION. AT THIS TIME, THE CUSTOMER HAS NOT ALLEGED THAT THIS MALFUNCTION CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT WAS UNDER DISTRESS AND UNSTABLE IN THE ER AND WAS BEING PREPARED FOR TRANSPORT TO ANOTHER FACILITY. A PH OF 6.940 WAS OBTAINED ON EPOC WITH A SAMPLE THAT WAS DIFFICULT TO OBTAIN. THE PATIENT WAS PROVIDED BICARBONATE. THE PATIENT CODED AND WAS UNABLE TO BE REVIVED FROM PULSELESS ELECTRICAL ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886949 EPOC BLOOD ANALYSIS SYSTEM EPOC READER CHL EPOCAL INC. 00809708016685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death