BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG CATHETER KIT

    MDR report key: 6602781 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00009
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    February 17, 2017
    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 IS A RESULT OF THE FDA 483 FILE NUMBER (B)(4) - OBSERVATION 1 - THIS INCIDENT OCCURED AFTER THE FINAL REPORT SO IS IN RESPONSE TO THE ACTION PLAN TAKEN. THE SUMMARY OF THE EVENT IS AS FOLLOWS: FURTHER INFORMATION PROVIDED BY THE TREATING PHYSICIAN SUPPORTS THE INITIAL CONCLUSION THAT THE HEMOLUNG RAS DID NOT CONTRIBUTE TO THE DEATH OF THE DESCRIBED PATIENT. THE HEMOLUNG CONTROLLER USED IN THIS CASE WAS THOROUGHLY INVESTIGATED BY ALUNG, SUBSEQUENT TO THE REPORT. IN REVIEWING THE DATA LOG FROM THE CONTROLLER, IT WAS OBSERVED THAT AN ALARM OCCURRED AT THE TIME OF PUMP STOPPAGE WHICH WAS CONCURRENT WITH A WEAKENED STATE OF THE BATTERIES. THE BATTERIES WERE EVALUATED AND FOUND TO BE WITHIN ALLOWABLE RANGE FOR OPERATION; HOWEVER, THE WEAKENED STATE MAY HAVE ALLOWED FOR THE VOLTAGE SIGNAL TO BE OUT OF RANGE. THE CONTROLLER RESPONDED TO THIS CONDITION AS INTENDED - IT RECOGNIZED THE CONDITION, GENERATED THE APPROPRIATE ALARM, AND AS PROGRAMMED FOR THIS CONDITION, STOPPED THE PUMP. CONCLUSION: THE HEMOLUNG RAS PROVIDES PARTIAL, NOT FULL, LUNG SUPPORT. IT IS NOT INTENDED TO, OR CAPABLE OF, PROVIDING FULL LIFE SUPPORT. AT THE TIME OF HEMOLUNG THERAPY CESSATION, THE PATIENT WAS RECEIVING LIFE SUPPORT VIA ENDOTRACHEAL INTUBATION AND INVASIVE MECHANICAL VENTILATION. AS REPORTED BY THE TREATING PHYSICIAN, THE PATIENT WAS CRITICALLY ILL WITH POOR PROGNOSIS OF SURVIVAL AT THE TIME OF THERAPY CESSATION. THE PHYSICIAN REPORTED AND CONFIRMED THAT CESSATION OF HEMOLUNG THERAPY DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THE CAUSE OF DEATH IS LISTED AS MULTI-ORGAN FAILURE AND WITHDRAWAL OF TREATMENTS. THE CONTROLLER USED DURING THIS CASE WAS FOUND TO HAVE FUNCTIONED AS INTENDED. IN THE ABUNDANCE OF CAUTION, THIS CONTROLLER HAS BEEN SERVICED; OXYGEN SENSORS AND BATTERIES WERE REPLACED AND TESTED TO CERTIFY EXPECTED FUNCTION. THE DEVICE ALSO RECEIVED ITS ANNUAL PREVENTATIVE MAINTENANCE AND CALIBRATION TESTING. THIS REPORT WAS SUBMITTED TO (B)(6) BUT AT THE POINT THE CLOSURE LETTER HAS NOT BEEN RECEIVED BY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382792 HEMOLUNG CATHETER KIT HEMOLUNG CATHETER KIT DQR ALUNG TECHNOLOGIES, INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death