BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG CATHETER KIT

    MDR report key: 6602757 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00007
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    April 2, 2016
    Report Date
    May 31, 2017
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS A RESULT OF (B)(4) AND ECPORTER RECEIVING A 483 FILE NUMBER (B)(4) - OBSERVATION 1. THE SUMMARY OF THE EVENT IS AS FOLLOWS: AFTER MULTIPLE ATTEMPTS TO RETRIEVE INFORMATION FROM THE TREATING PHYSICIAN, (B)(4) RECEIVED THE HEMOLUNG REGISTRY FORM FROM DR. (B)(6), ON (B)(6) 2016. THE PHYSICIAN INDICATED THAT THE CEREBRAL HEMORRHAGE AND SUBSEQUENT DEATH WERE DEFINITELY RELATED TO HEMOLUNG THERAPY SECONDARY TO THE NEED FOR ANTICOAGULATION. DR. (B)(6) INDICATED THE HEMOLUNG DEVICE WAS FUNCTIONING AS EXPECTED ALLOWING FOR IMPROVED LUNG PROTECTIVE VENTILATION WITH DESIRED CO2 REMOVAL. OUT OF AN ABUNDANCE OF CAUTION, (B)(4) IS REPORTING THIS INCIDENT. MORE INFORMATION IS ATTEMPTED TO BE GATHERED FROM DR. (B)(6) AT THIS TIME. HEMORRHAGE IS, AGAIN, A KNOWN COMPLICATION OF ANY EXTRACORPOREAL DEVICE, INCLUDING THE HEMOLUNG RAS, DUE TO THE REQUIRED NEED OF HEPARIN FOR ANTICOAGULATION PURPOSES. THESE COMPLICATIONS ARE COVERED IN HEMOLUNG TRAININGS AND ARE LABELED APPROPRIATELY IN THE POTENTIAL COMPLICATIONS SECTION OF THE HEMOLUNG RAS INSTRUCTIONS FOR USE. (B)(4) CONTINUOUSLY MONITORS FOR THESE TYPES OF REPORTED COMPLICATIONS AND WILL CONTINUE TO DO SO. THIS REPORT WAS SUBMITTED TO MHRA AND CLOSED SEE ATTACHED REPORT AND CLOSURE LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382502 HEMOLUNG CATHETER KIT HEMOLUNG CATHETER KIT DQR ALUNG TECHNOLOGIES, INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death