BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLUNG CATHERETE KIT

    MDR report key: 6602761 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00008
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    October 16, 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 IS A RESULT OF FDA 483 FILE NUMBER 3009763347 - OBSERVATION 1 THE FOLLOWING IS THE SUMMARY IN THE FINAL REPORT: PATIENT SUMMARY: THIS SUMMARY IS FOR A (B)(6) FEMALE WHO PRESENTED TO HOSPITAL (B)(6) FROM AN OUTLYING HOSPITAL FOR AN ACUTE EXACERBATION OF COPD. THE PATIENT WAS INTUBATED ON MECHANICAL VENTILATION FOR 10 DAYS PRIOR TO TRANSFER WITH BACTERIAL PNEUMONIA AND POSITIVE FOR RHINOVIRUS. TRANSFER TOOK PLACE DUE TO DIFFICULTY WEANING FROM MECHANICAL VENTILATION AND PATIENT WAS A GOOD CANDIDATE FOR ECCO2R. THE PATIENT HAD A PAST MEDICAL HISTORY OF SEVERE COPD, CAD AND HTN. THE PATIENT WAS CANNULATED WITH A 15.5 FR HEMOLUNG RAS JUGULAR CATHETER WITHOUT INCIDENT. CHEST X-RAY CONFIRMED PROPER PLACEMENT. IT WAS NOTED THAT THE PATIENT WAS OVER ANTICOAGULATED AND WITH REDUCTION IN HEPARIN ADMINISTRATION, THE ACT RANGE WAS ON TARGET WITHIN FOUR HOURS OF HEMOLUNG THERAPY. APPROXIMATELY 10 HOURS INTO HEMOLUNG THERAPY, THE PATIENT STARTED EXPERIENCING HEMODYNAMIC INSTABILITY WHICH WAS DETERMINED TO BE CAUSED BY A PERICARDIAL EFFUSION WITH CARDIAC COMPRESSION AND WITHIN 20 HOURS OF HEMOLUNG THERAPY AND FURTHER MEDICAL TREATMENT THE PATIENT EXPERIENCED HEMODYNAMIC COLLAPSE AND EVENTUAL DEATH. NO AUTOPSY WAS PERFORMED. CONCLUSION: AT THIS TIME, IT IS UNABLE TO BE DETERMINED THE EXACT CAUSE OF THE PERICARDIAL EFFUSION. A PRE-EXISTING EFFUSION IS A POSSIBILITY AND UNABLE TO BE RULED OUT. WHILE TRAUMA CAUSED BY CANNULATION IS ALSO A POSSIBILITY, THE PHYSICIAN STATED THAT THERE WAS NO INDICATION OF SUCH TRAUMA AT THE TIME OF CANNULA INSERTION OR IMMEDIATELY FOLLOWING. CANNULA PLACEMENT WAS CONFIRMED WITH A CHEST X-RAY AND THE PATIENT SHOWED NO SIGNS OF DISTRESS. WHILE EITHER OPTION IS A POSSIBILITY, HIGHER LEVELS OF ANTICOAGULATION COULD EXACERBATE THE EFFUSION REGARDLESS OF THE CAUSE. WITH NO AUTOPSY, THE EXACT ORIGIN CANNOT BE DETERMINED. THE FINAL REPORT WAS SUBMITTED TO ANSM AND CLOSED BY ANSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382506 HEMOLUNG CATHERETE KIT HEMOLUNG CATHETER KIT DQR ALUNG TECHNOLOGIES INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death