BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABL80

    MDR report key: 23290747 · Received October 15, 2025

    Report

    Report Number
    0002027541-2025-00003
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 14, 2025
    Manufacturer
    SENDX MEDICAL, INC
    Product Code
    CHL
    UDI-DI
    05700693938394
    PMA / PMN Number
    K051804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS SHOWN THAT PART NUMBERS ASSOCIATED TO THIS CASE ARE NOT MARKETED IN THE UNITED STATES. THEREFORE, THIS INCIDENT DOES NOT MEET THE CRITERIA FOR A REPORTABLE MDR.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED, ON (B)(6) 2025, AT 15:29, TWO BLOOD SAMPLES WERE SIMULTANEOUSLY DRAWN FROM THE PATIENT. ONE SAMPLE WAS USED FOR BLOOD GAS ANALYSIS ON ABL80 ANALYZER, WHILE THE OTHER WAS SENT TO THE LABORATORY FOR STAT RENAL FUNCTION TESTING. AT 15:49, THE ABL80 RESULT SHOWED A CRITICAL SODIUM VALUE OF 200 MMOL/L. UPON RECEIVING THE REPORT, THE PHYSICIAN IMMEDIATELY ASSESSED THE PATIENT, CONSIDERING POTENTIAL COMPLICATIONS SUCH AS ELECTROLYTE IMBALANCE, MULTIPLE ORGAN DYSFUNCTION, ACUTE KIDNEY INJURY, DEHYDRATION, ARRHYTHMIA, AND SUDDEN CARDIAC ARREST. IMMEDIATE ACTIONS INCLUDED UPGRADING THE PATIENT'S CARE LEVEL TO INTENSIVE, INITIATING CARDIAC MONITORING, DECLARING THE PATIENT'S CONDITION AS CRITICAL, AND ADMINISTERING DIURETICS AND FLUID REPLACEMENT TO LOWER SODIUM LEVELS, WHILE CLOSELY MONITORING THE PATIENT'S STATUS. AT 16:52, THE STAT RENAL FUNCTION TEST REPORT (FROM THE SAMPLE DRAWN AT THE SAME TIME AS THE BLOOD GAS ANALYSIS) SHOWED A SODIUM LEVEL OF 130 MMOL/L, INDICATING HYPONATREMIA. THE PHYSICIAN IMMEDIATELY DISCONTINUED THE DIURETICS AND INITIATED SODIUM SUPPLEMENTATION THERAPY. AT 22:43 THAT SAME DAY, A REPEAT STAT ELECTROLYTE TEST SHOWED A SODIUM LEVEL OF 132.0 MMOL/L. THE TWO INITIAL SODIUM RESULTS DIFFERED BY 70 MMOL/L, INDICATING A SEVERE DEVIATION. DUE TO THE DISCREPANT SODIUM RESULTS, THE TREATMENTS ADMINISTERED TO THE PATIENT WERE CONTRADICTORY. THE PATIENT EXPERIENCED AN ELECTROLYTE IMBALANCE, REQUIRING SUBSEQUENT ADJUSTMENT OF MEDICATION AND MONITORING OF VITAL SIGNS. THIS INCIDENT RESULTED IN HARM TO THE PATIENT.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED, ON (B)(6) 2025, AT 15:29, TWO BLOOD SAMPLES WERE SIMULTANEOUSLY DRAWN FROM THE PATIENT. ONE SAMPLE WAS USED FOR BLOOD GAS ANALYSIS ON ABL80 ANALYZER, WHILE THE OTHER WAS SENT TO THE LABORATORY FOR STAT RENAL FUNCTION TESTING. AT 15:49, THE ABL80 RESULT SHOWED A CRITICAL SODIUM VALUE OF 200 MMOL/L. UPON RECEIVING THE REPORT, THE PHYSICIAN IMMEDIATELY ASSESSED THE PATIENT, CONSIDERING POTENTIAL COMPLICATIONS SUCH AS ELECTROLYTE IMBALANCE, MULTIPLE ORGAN DYSFUNCTION, ACUTE KIDNEY INJURY, DEHYDRATION, ARRHYTHMIA, AND SUDDEN CARDIAC ARREST. IMMEDIATE ACTIONS INCLUDED UPGRADING THE PATIENT'S CARE LEVEL TO INTENSIVE, INITIATING CARDIAC MONITORING, DECLARING THE PATIENT'S CONDITION AS CRITICAL, AND ADMINISTERING DIURETICS AND FLUID REPLACEMENT TO LOWER SODIUM LEVELS, WHILE CLOSELY MONITORING THE PATIENT'S STATUS. AT 16:52, THE STAT RENAL FUNCTION TEST REPORT (FROM THE SAMPLE DRAWN AT THE SAME TIME AS THE BLOOD GAS ANALYSIS) SHOWED A SODIUM LEVEL OF 130 MMOL/L, INDICATING HYPONATREMIA. THE PHYSICIAN IMMEDIATELY DISCONTINUED THE DIURETICS AND INITIATED SODIUM SUPPLEMENTATION THERAPY. AT 22:43 THAT SAME DAY, A REPEAT STAT ELECTROLYTE TEST SHOWED A SODIUM LEVEL OF 132.0 MMOL/L. THE TWO INITIAL SODIUM RESULTS DIFFERED BY 70 MMOL/L, INDICATING A SEVERE DEVIATION. DUE TO THE DISCREPANT SODIUM RESULTS, THE TREATMENTS ADMINISTERED TO THE PATIENT WERE CONTRADICTORY. THE PATIENT EXPERIENCED AN ELECTROLYTE IMBALANCE, REQUIRING SUBSEQUENT ADJUSTMENT OF MEDICATION AND MONITORING OF VITAL SIGNS. THIS INCIDENT RESULTED IN HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337768 ABL80 ABL80 FLEX BLOOD-GASES ANALYZER, PRODUCT CODE: CHL, PRODUCT CODE: CHL CHL SENDX MEDICAL, INC 393-839 05700693938394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention