BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOWNSTREAM® SYSTEM

    MDR report key: 22601207 · Received July 24, 2025

    Report

    Report Number
    2030964-2025-00002
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 24, 2025
    Manufacturer
    THEROX, INC.
    Product Code
    MWG
    PMA / PMN Number
    P170027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOWNSTREAM CONSOLE (SN (B)(6)) WAS NOT RETURNED TO ZOLL FOR EVALUATION; HOWEVER, THE EVENT LOG WAS DOWNLOADED FROM THE CONSOLE AND REVIEWED. THE ANALYSIS OF THE CONSOLE LOG FILES CONFIRMED THAT THE CATHETER WAS CONNECTED TO THE RETURN LINE PRIOR TO PRIMING THE CIRCUIT FOR THERAPY. CIRCUIT PRESSURE WAS MEASURED AT ARTERIAL LEVELS, AND FLOW PROBE SIGNAL WAS DETECTED (BLOOD PRIMED ANTEGRADE FROM CATHETER THROUGH RETURN LINE PAST FLOW PROBE) BEFORE THE PRIMING SEQUENCE WAS STARTED (PUMP STARTED). A SMALL AMOUNT OF AIR WAS TRAPPED ABOVE THE FLOW PROBE, NOTED BECAUSE THE FLOW PROBE LOST SIGNAL FOR LESS THAN TWO SECONDS DURING THE PRIMING SEQUENCE. THE PROCEDURE WAS STOPPED BY DISCONNECTING THE CATHETER AT THE END OF THE PRIME SEQUENCE (SYSTEM SHUTDOWN FOR SUDDEN SPIKE IN BLOOD FLOW RATE). THE AIR BUBBLE (LESS THAN 1 ML AT PRIMING FLOW RATES) WOULD HAVE TRAVELED TO THE PATIENT AT ABOUT THE TIME THE PROCEDURE WAS STOPPED. PER THE DOWNSTREAM SYSTEM (MODEL DS-2) OPERATORS MANUAL, PRIMING THE BLOOD PATH, WARNING: VERIFY THAT ALL CONNECTIONS ARE SECURE AND TIGHT PRIOR TO INITIATING PRIME. VERIFY THAT THE RETURN LINE OF THE CARTRIDGE IS NOT CONNECTED TO THE SSO2 CATHETER PRIOR TO INITIATING PRIME. SUPERSATURATED OXYGEN (SSO2) THERAPY IS AN ADJUNCTIVE CARDIAC CATHETERIZATION LABORATORY INITIATED PROCEDURE TARGETED AT THE LEFT MAIN CORONARY ARTERY (LMCA) OF AN ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT AFTER SUCCESSFUL PERCUTANEOUS INTERVENTION (PCI) WITH STENTING HAS BEEN PERFORMED OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE THEROX DOWNSTREAM SYSTEM IS INDICATED FOR THE PREPARATION AND DELIVERY OF SUPERSATURATED OXYGEN THERAPY (SSO2 THERAPY) TO TARGETED ISCHEMIC REGIONS PERFUSED BY THE PATIENT'S LEFT ANTERIOR DESCENDING CORONARY ARTERY IMMEDIATELY FOLLOWING REVASCULARIZATION BY MEANS OF PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENTING THAT HAS BEEN COMPLETED WITHIN 6 HOURS AFTER THE ONSET OF ANTERIOR ACUTE MYOCARDIAL INFARCTION (AMI) SYMPTOMS CAUSED BY A LEFT ANTERIOR DESCENDING ARTERY INFARCT LESION. EVENT OF AIR EMBOLISM WITH OUTCOME OF CARDIAC ARREST WAS SERIOUS AS EVENT WAS LIFE THREATENING. ACCORDING TO AVAILABLE INFORMATION, EVENT ASSESSED AS CAUSAL RELATED TO THEROX CONSOLE AND TO THE PROCEDURE DUE TO USE ERROR. THE CUSTOMER PROBABLY WILL BENEFIT FROM ADDITIONAL FOLLOW-UP TRAINING. THE ZOLL CLINICAL ACCOUNT SPECIALIST CONDUCTED FOCUSED IN-SERVICE TRAINING SESSIONS FOR STAFF, ENGAGED WITH DESIGNATED PROVIDERS TO REVIEW CLINICAL CASES AND DEVELOP PREVENTIVE CARE STRATEGIES, AND COORDINATED UPCOMING EDUCATIONAL SESSIONS FOR PHYSICIANS.

    Description of Event or Problem · 0

    THE PATIENT WAS POSITIONED ON THE TABLE, AND VASCULAR ACCESS WAS OBTAINED. ACCORDING TO THE PHYSICIAN, DURING PRIMING OF THE DOWNSTREAM CONSOLE (SN (B)(6)), THE RETURN LINE WAS CONNECTED TO THE SSO2 CATHETER BEFORE THE LINE WAS FULLY PRIMED. THIS LED TO THE INTRODUCTION OF AN AIR EMBOLISM, RESULTING IN CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND AN IMPELLA DEVICE WAS PLACED. FOLLOWING RESUSCITATION AND IMPELLA DEVICE PLACEMENT, THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044811 DOWNSTREAM® SYSTEM SYSTEM, OXYGEN, AQUEOUS MWG THEROX, INC. DS-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R