BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOVENT

    MDR report key: 981925 · Received January 22, 2008

    Report

    Report Number
    2112667-2008-00003
    Event Type
    Death
    Date Received
    January 22, 2008
    Date of Event
    December 21, 2007
    Report Date
    January 22, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    MRN
    PMA / PMN Number
    K974562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PER MEDWATCH REPORT FROM IKARIA: "A FEMALE INFANT WAS BORN IN 2007 WITH A WEIGHT OF 3.6 KILOGRAMS. SHE WAS DELIVERED VIA CESAREAN SECTION DUE TO FETAL DISTRESS. SHE REQUIRED TRANSFER TO ANOTHER FACILITY FOR AORTIC ARCH RECONSTRUCTION AND A NORWOOD PROCEDURE. ON SEVENTEEN DAYS LATER, THE INFANT WAS DISCONTINUED FROM EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) AND PLACED ON INOMAX AT 20 PARTS PER MILLION FOR THE TREATMENT OF PULMONARY HYPERTENSION. ON THE NEXT DAY, THE GAS OUTLET LINE FROM THE JET VENTILATOR BECAME DISCONNECTED. THE INFANT DEVELOPED BRACHYCARDIA. INOVENT HAD A HIGH NITRIC OXIDE LEVEL ALARM (OVER 24 PARTS PER MILLION AND RISING) AND WAS PLACED ON MANUAL STANDBY. HER SPO2 WAS BELOW 60%, HEART RATE AND BLOOD PRESSURE DECREASED. SHE WAS HAND BAGGED WITH INOMAX AND 100% OXYGEN. THE STAFF FOUND THE TUBING LEADING TO THE INJECTOR MODULE SATURATED WITH WATER. THE STAFF DID A LOW RANGE PURGE OF THE LINE AND A CALIBRATION. THE INFANT EXPERIENCED HYPOTENSION RESULTING IN CARDIOPULMONARY ARREST. RESUSCITATION EFFORTS WERE UNSUCCESSFUL. THE INFANT EXPIRED ON THE SAME DAY." GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOVENT NITRIC OXIDE DELIVERY SYSTEM MRN DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 DA Death