BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG RESPIRATORY ASSIST SYSTEM

    MDR report key: 6602635 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00002
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    August 8, 2014
    Report Date
    May 26, 2017
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING PROVIDED AS A RESULT OF FDA 483 FILE NUMBER 3009763347 - OBSERVATION 1. THE FINAL SUMMARY IS INCLUDED IN THE FINAL INCIDENT REPORT AND IS SUMMARIZED BELOW. BASED UPON FINAL INFORMATION PROVIDED BY THE PHYSICIAN, ALUNG CANNOT DEFINITIVELY RELATE THE PATIENT'S CAUSE OF DEATH -- MULTI-ORGAN FAILURE -- TO THE USE OF THE HEMOLUNG DEVICE. THIS IS THE FIRST REPORT OF ITS KIND. ALUNG WILL CONTINUE TO PROACTIVELY MONITOR THESE TYPES OF EVENTS. THE INCIDENT REPORT WAS CLOSED BY (B)(6).

    Description of Event or Problem · 1

    AS FIRST REPORTED ON 18 AUGUST 2014, ALUNG RECEIVED A BRIEF REPORT OF A PATIENT DEATH UNRELATED TO THE HEMOLUNG RAS ON (B)(6) 2014. THE EXACT CAUSE OF THE DEATH CANNOT YET BE DETERMINED. AN AUTOPSY WAS NOT PERFORMED. THE HEMOLUNG CARTRIDGE AND CATHETERS COULD NOT BE RETURNED FOR FURTHER EXPLANT ANALYSIS. ADDITIONAL INFORMATION FROM THE TREATING PHYSICIAN COULD ONLY BE OBTAINED ON (B)(6) 2014, DUE TO THE PHYSICIAN'S SCHEDULE. ON (B)(6) THE PHYSICIAN REPORTED A (B)(6) YEAR OLD FEMALE WHO WAS ON INVASIVE MECHANICAL VENTILATION EXPERIENCED CARBON DIOXIDE RETENTION, AND HE SOUGHT TO USE THE HEMOLUNG RAS DEVICE AS AN ADJUNCT TO THE VENTILATOR IN ORDER TO CORRECT THE PATIENT'S HYPERCAPNIA. THE CANNULATION PROCEDURE WAS UNEVENTFUL. AT AROUND HOUR 60, THE PATIENT EXPERIENCED HEMOLYSIS AND WORSENING PROCALCITONIN AND C-REACTIVE PROTEIN (CRP) LEVELS. THE PATIENT DID NOT EXPERIENCE A FEVER. TWO UNITS OF ERYTHROCYTE CONCENTRATES AND 5 UNITS OF PLATELETS WERE GIVEN AS A RESULT OF A BLEEDING EVENT IN THE CHEST TUBE. HEPARIN LEVELS WERE REDUCED FROM HER BLEEDING. SHE WAS HEMODYNAMICALLY STABLE WITH MODEST LEVELS OF CATECHOLAMINES. ON DAY 5, THE PATIENT DIED OF MULTI-ORGAN FAILURE WHILE ON HEMOLUNG. HEMOLYSIS, BLEEDING, AND INFLAMMATORY RESPONSES ARE INCLUDED IN ALUNG'S RISK DOCUMENTATION, AND ARE EXPECTED COMPLICATIONS ASSOCIATED WITH EXTRACORPOREAL THERAPIES. ON SEPTEMBER 6, THE PHYSICIAN COULD NOT OFFER A SPECIFIC CAUSE OF DEATH. ALUNG HAS NOT RECEIVED ANY OTHER SIMILAR REPORTS OF PATIENTS TREATED ON THE HEMOLUNG RAS AND THIS EVENT APPEARS TO BE AN ANOMALY. ALUNG HAS REQUESTED ADDITIONAL DATA FROM THE PHYSICIAN. THE EVENT REMAINS UNDER INVESTIGATION. MANUFACTURER'S FOLLOW-UP REPORT - 17 OCTOBER 2014, ALUNG HAS ATTEMPTED TO DOWNLOAD AND ACCESS THE BFARM FORM FROM THE WEBSITE ADDRESS: (B)(4) WITHOUT SUCCESS. THIS FOLLOW-UP REPORT IS BEING SUBMITTED ON A STANDARD INCIDENT REPORT FORM INSTEAD. ALUNG IS STILL IN THE PROCESS OF COLLECTING INFORMATION FROM THE PHYSICIAN AND THIS INVESTIGATION REMAINS OPEN. THE HEMOLUNG CARTRIDGE AND CATHETERS WERE DISPOSED AT THE SITE IN ACCORDANCE WITH HOSPITAL POLICY AND COULD NOT BE RETURNED FOR ALUNG'S INVESTIGATION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383245 HEMOLUNG RESPIRATORY ASSIST SYSTEM HEMOLUNG RESPIRATORY ASSIST SYSTEM DQR ALUNG TECHNOLOGIES, INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death