BEUDAMED
    FDA Adverse Event Death Summary report: N

    DATEX-OHMEDA INOVENT SYSTEM

    MDR report key: 1369217 · Received April 9, 2009

    Report

    Report Number
    1369217
    Event Type
    Death
    Date Received
    April 9, 2009
    Date of Event
    January 14, 2009
    Report Date
    April 9, 2009
    Manufacturer
    IKARIA INO THERAPEUTICS INC
    Product Code
    MRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PT HAD A DIAGNOSIS OF IPF AND ACUTE RESPIRATORY FAILURE. WAS MAINTAINED IN THE ICU INTUBATED, SEDATED AND FULLY SUPPORTED ON A VENTILATOR RECEIVING INHALED NITRIC OXIDE THRU AN INO VENT DELIVERY DEVICE. PT WAS TRANSPORTED FROM ICU TO OR FOR RT. LUNG TRANSPLANT WITHOUT INCIDENT. WHILE PT WAS WAS IN OR RECEIVING NITRIC OXIDE THRU THE INOVENT AND PRIOR TO SURGERY, THERE WAS A FAILURE OF THE INOVENT MACHINE. THE PT SUFFERED AN ARREST, CPR WAS INITIATED, PT GIVEN EPINEPHRINE, AND REGAINED HIS BLOOD PRESSURE. THE INOVENT MACHINE WAS CHANGED OUT FOR ANOTHER MACHINE. THE PT WAS EMERGENTLY PLACED ON BYPASS AND THE SURGERY PROCEEDED. POST-OP THE PT WAS SENT BACK TO ICU,UNDERWENT 2 ADDITIONAL SURGERIES, A MEDIASTINAL EXPLORATION AND WASHOUT THE NEXT DAY AND DECANNULATION FROM EXTRACORPOREAL LIFE SUPPORT/REMOVAL OF EXTRACORPOREAL VENTRICULAR ASSIST DEVICE THREE DAYS AFTER EVENT OCCURRED. PT HAD DETERIORATING NEUROLOGICAL STATUS AND WEEKS LATER HAD BRAIN CT. SHOWED MULTIPLE FOCI OF HEMORRHAGE IN THE RT PARIETAL AND RT FRONTAL LOBES AS WELL AS SUBARACHNOID HEMORRHAGE IN LEFT FRONTAL AND LEFT PARIETAL LOBES. ALSO A SMALL INTRAVENTRICULAR HEMORRHAGE WAS NOTED. PT'S SURGEON AND PT FAMILY OPTED TO WITHDRAW CARE AND PT EXPIRED.====================== MANUFACTURER RESPONSE FOR NITRIC OXIDE GAS & DELIVERY SYSTEM, DATEX-OHMEDA======================WILL EVALUATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA INOVENT SYSTEM NITRIC OXIDE GAS & DELIVERY SYSTEM MRN IKARIA INO THERAPEUTICS INC 1605-9000-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death