BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG RAS

    MDR report key: 16200028 · Received January 18, 2023

    Report

    Report Number
    3009763347-2023-00058
    Event Type
    Death
    Date Received
    January 18, 2023
    Date of Event
    August 1, 2020
    Report Date
    January 18, 2023
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    QLN
    UDI-DI
    00850046004162
    PMA / PMN Number
    DEN0210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(6). ALUNG TECHNOLOGIES, INC. WAS NOTIFIED THAT DURING CATHETER, THE PHYSICIAN HAD DIFFICULTY IN WHICH TWO UNSUCCESSFUL IJ ATTEMPTS WERE MADE, FOLLOWED BY A SUCCESSFUL FEMORAL CATHETER. THE NOTIFICATION INCLUDED THAT THE PATIENT HAD SEVERE VASCULAR DISEASE. ALUNG TECHNOLOGIES, INC. WAS THEN LATER NOTIFIED THAT THE PATIENT EXPERIENCED A MEDIASTINAL HEMATOMA, SECONDARY TO VASCULAR COMPLICATION FROM CATHETER. ALUNG TECHNOLOGIES, INC. WAS THEN NOTIFIED OF THE PATIENT'S DEATH. FURTHER DISCUSSION WITH THE TREATING PHYSICIAN INCLUDED THAT THE PATIENT WAS ALMOST TERMINALLY ILL WITH MULTIPLE COMORBIDITIES, INCLUDING COPD, ARDS (COVID-19 POSITIVE), DIABETES, AND IN SEPTIC SHOCK DUE TO RIGHT LEG ISCHEMIA. THE PATIENT WAS AT RISK FOR A RIGHT LEG AMPUTATION. THE CATHETERIZING PHYSICIAN IS A WELL EXPERIENCED CARDIOTHORACIC SURGEON WITH PREVIOUS SUCCESSFUL HEMOLUNG CATHETERS. HE USED ULTRASOUND TO ASSIST IN THIS CATHETER. WITH THE FIRST IJ CATHETER ATTEMPT, THE DILATOR AND GUIDEWIRE WERE BOTH PLACED SUCCESSFULLY, BUT THE CATHETER WAS UNABLE TO ADVANCE MORE THAN 3-4 CM THE CATHETER WAS REMOVED, AND THE DILATOR WAS THEN PLACED BACK OVER THE GUIDEWIRE IN ATTEMPT TO DILATE THE VESSEL FURTHER. IT WAS THEN NOTED THAT THE GUIDEWIRE WAS DIFFICULT TO MOVE. THE PHYSICIAN THEN ATTEMPTED ANOTHER PUNCTURE, ADJACENT TO THE EXISTING GUIDEWIRE TO MAINTAIN PATENCY OF THE VESSEL. AT THIS TIME THEY OBSERVED THE HEMATOMA. WHEN THE INITIAL GUIDEWIRE WAS REMOVED FROM THE IJ, THE GUIDEWIRE AND DILATOR HAD TO BE REMOVED TOGETHER DUE TO SIGNIFICANT KINKING OF THE GUIDEWIRE. DURING THIS TIME, THE PATIENT BEGAN TO DECOMPENSATE. HYPOTENSION AND HYPOXIA WERE NOTED. PRESSURE WAS HELD AT THE SITE OF THE HEMATOMA. FOUR UNITS OF BLOOD AND ALBUMIN WERE ADMINISTERED. A RIGHT CHEST TUBE WAS PLACED. ECHO SHOWED NO FREE BLOOD IN THE CHEST CAVITY. THE PATIENT THEN STABILIZED. THE PHYSICIAN SUSPECTS THE PATIENT MAY HAVE HAD ANOMALOUS ANATOMY, POSSIBLY ATTRIBUTING TO THE CATHETER COMPLICATION. THERE WAS A QUESTIONABLE "LESION" NOTED ON X-RAY, BUT NO RADIOLOGY REPORT OR CT AVAILABLE. DR. (B)(6) FELT CONFIDENT THAT ONCE THE PATIENT WAS STABILIZED, THEY COULD CONTINUE WITH CATHETERIZING FOR HEMOLUNG THERAPY. A RIGHT FEMORAL CATHETER WAS SUCCESSFUL WITHOUT NOTED COMPLICATIONS. APPROXIMATELY 30 MINUTES AFTER INITIATION OF HEMOLUNG THERAPY, THE PATIENT BEGAN TO DETERIORATE; THERE WAS BLOOD PRESENT IN THE CHEST TUBE AND AROUND THE HEART. THE PATIENT WENT INTO CARDIAC ARREST AND CPR WAS ADMINISTERED FOR APPROXIMATELY 15 MINUTES WITHOUT SUCCESS. THE PHYSICIAN SPECULATES AN AUTOPSY WILL NOT BE PERFORMED ON THE PATIENT. THE PHYSICIAN FEELS CONFIDENT THAT EVERYTHING WAS PERFORMED CORRECTLY AND THAT THERE WERE NO DEFECTS IN THE CONSUMABLES USED IN THE PROCESSES. THE USED CONSUMABLES ARE UNABLE TO BE RETURNED FOR ANALYSIS AT ALUNG TECHNOLOGIES, INC. AS THEY WERE DISCARDED SINCE THE PATIENT WAS COVID-19 POSITIVE. THE SITE STAFF IS STILL CONFIDENT IN USING THE HEMOLUNG TREATMENT AND DOES NOT FEEL THEY NEED ANY FURTHER TRAINING AT THIS TIME. THE DATA LOG HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. NO UNEXPECTED LEVELS OR ALARMS WERE NOTED WITHIN THE CO2 REMOVAL AND BLOOD FLOW GRAPHS; THE GRAPHS COINCIDE WITH THE PATIENT'S CRITICAL STATUS AND DETERIORATION. NO UNEXPECTED ALARMS OR CRITICAL ERRORS OCCURRED. HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. BLEEDING, INCLUDING MEDIASTINAL HEMATOMA AND PERICARDIAL EFFUSION, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH THE USE OF EXTRACORPOREAL HEMOLUNG THERAPY. BASED ON THE FOLLOW UP DISCUSSIONS WITH THE PHYSICIAN, IT IS BELIEVED THAT THERE WERE NO DEFECTS IN THE PRODUCT THAT CONTRIBUTED TO THIS CLINICAL COMPLICATION AND THAT HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. ALUNG TECHNOLOGIES, INC. WILL CONTINUE TO MONITOR ANY ISSUES AS THEY ARE REPORTED. THIS MDR IS BEING FILED IN RESPONSE TO A RETROSPECTIVE VIEW OF ALL ALUNG TECHNOLOGIES, INC. COMPLAINTS, WHICH IDENTIFIED THAT THE REPORTING DECISION FOR THIS COMPLAINT WAS NOT CORRECT. THIS MDR IS BEING FILED RETROSPECTIVELY TO CORRECT THE ERROR IN THE REPORTING DECISION.

    Description of Event or Problem · 0

    ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT THAT A PATIENT HAD MULTIPLE CATHETER ATTEMPTS TAKE PLACE DURING HEMOLUNG THERAPY. DURING THESE ATTEMPTS THE PATIENT BEGAN TO DECOMPENSATE. THE PATIENT EXPERIENCED A MEDIASTINAL HEMATOMA, SECONDARY TO VASCULAR COMPLICATION FROM CATHETER. AFTER 4 UNITS OF BLOOD WERE GIVEN AND A CHEST TUBE WAS PLACED THE PATIENT STABILIZED AND THE PHYSICIAN DECIDED TO CONTINUE WITH CATHETER FOR HEMOLUNG THERAPY. AFTER 30 MINUTES OF HEMOLUNG THERAPY THE PATIENT DETERIORATED AND BLOOD WAS SEEN AROUND THE CHEST TUBE. THE PATIENT WENT INTO CARDIAC ARREST AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406355 HEMOLUNG RAS EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL FOR THE TREATMENT OF COVID-19 QLN ALUNG TECHNOLOGIES, INC. HL-CA09-00-000 00850046004162

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D| L