BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG 15.5 JUGULAR CATHETER KIT

    MDR report key: 6602577 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00001
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    March 17, 2014
    Report Date
    May 26, 2017
    Manufacturer
    ALUNG TECHNOLOGIES INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO THE INCIDENT REPORT SENT TO (B)(6) COMPETENT AUTHORITY. THIS EMDR IS A RESULT OF FDA 483 FILE NUMBER 3009763347 - OBSERVATION 1. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REFER TO THE INCIDENT REPORT SUBMITTED TO (B)(6), COMPETENT AUTHORITY. THE FINAL REPORT IS SUMMARIZED BELOW: THE MANUFACTURER'S DEVICE ANALYSIS RESULTS: THIS (B)(6) YEAR OLD CRITICALLY ILL FEMALE PATIENT HAD A PRIOR HISTORY OF CHRONIC ISCHEMIC HEART DISEASE AND TIGHT AORTIC STENOSIS. PRIOR TO HEMOLUNG THERAPY, THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT AND RECEIVED A BIOLOGIC AORTIC VALVE PROSTHESIS. TWO DAYS LATER HER RESPIRATORY FAILURE WAS WORSENING. SHE BECAME HEMODYNAMICALLY UNSTABLE AND HER ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) WAS PROGRESSING MAKING OXYGENATION AND CO2 REMOVAL DIFFICULT TO ACHIEVE ON INVASIVE MECHANICAL VENTILATION. HEMOLUNG THERAPY WAS AGREED UPON BY THE PATIENT'S SON TO ADDRESS HER CO2 RETENTION. THE PHYSICIAN FOLLOWED STANDARD CANNULATION PROCEDURES BUT THE GUIDEWIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA WHERE IT PENETRATED THE VESSEL IN A MEDIAL AND VENTRAL DIRECTION INTO THE HILUS OF THE RIGHT LUNG AND INTO THE PROXIMAL PARTS OF THE MIDDLE AND INFERIOR LUNG LOBES. AT AUTOPSY, PROFUSE AMOUNTS OF BLOOD WERE FOUND IN THE TRACHEA, RIGHT HILUM AND PROXIMAL PARTS OF THE MID AND SUPERIOR LOBE. THIS HEMORRHAGIC EVENT CAUSED ACUTE CIRCULATORY COLLAPSE, ASYSTOLE, AND DEATH. THIS EVENT IS A KNOWN RISK OF THE CANNULATION PROCEDURE AND IS INCLUDED IN ALUNG'S RISK DOCUMENTATION. FOLLOWING THE REVIEW OF THE PHYSICIAN'S REPORT AND AUTOPSY REPORT, ALUNG HAS DETERMINED THAT WHILE THIS IS A KNOWN COMPLICATION, SUBOPTIMAL CATHETER PLACEMENT TECHNIQUE CANNOT BE RULED OUT. THIS IS OUR FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382633 HEMOLUNG 15.5 JUGULAR CATHETER KIT HEMOLUNG 15.5 FR JUGULAR CATHETER KIT DQR ALUNG TECHNOLOGIES INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death