BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOVENT (DELIVERY SYSTEM)

    MDR report key: 1705517 · Received May 28, 2010

    Report

    Report Number
    2112667-2010-00017
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    May 2, 2010
    Report Date
    May 28, 2010
    Manufacturer
    DATEX-OHMEDA
    Product Code
    MRN
    PMA / PMN Number
    K000186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER OUTCOME - MEDICALLY SIGNIFICANT. INOVENT ALARMED AND SHUT-DOWN WHILST BABY WAS DISCONNECTED FOR A MEDICAL PROCEDURE. THE INOVENT WAS NOT PAUSED AND THE VENTILATOR CIRCUIT WAS CAPPED. DEVICE WAS RESTARTED SUCCESSFULLY FOLLOWING GUIDANCE VIA TELEPHONE FROM INOTHERAPEUTICS REPRESENTATIVE. BABY'S SAO2 LEVELS RETURNED TO PREVIOUS LEVEL FOLLOWING RE-CONNECTION. THE BABY SUBSEQUENTLY DIED LATER THE SAME DAY WHICH WAS A FULLY EXPECTED EVENT. THE STAFF WAS ADVISED THE INOVENT SHOULD BE PAUSED OR SWITCHED OFF IF THE VENTILATOR CIRCUIT IS CAPPED AS THIS WILL CAUSE A BUILD-UP OF GAS CONCENTRATION AND THE MACHINE WILL SWITCH ITSELF OFF AS A SAFETY MEASURE. EVAL SUMMARY: THE MACHINE'S ALARM LOG WAS ACCESSED AND SHOWED THAT TWO EVENTS OF HIGH NITRIC OXIDE READING RESULTING IN ELECTRONIC SHUT-DOWN IN LINE WITH THE PT SAFETY FEATURE IN THE FUNCTIONAL SPECIFICATION HAD OCCURRED IN SUCCESSION. NO FAULT WAS FOUND IN THE FUNCTIONALITY OF THE MACHINE WHICH WAS PUT ON A FIVE DAY TEST RUN. THE MACHINE WAS THEN SERVICED AND WILL BE RETURNED TO THE CUSTOMER POOL OF DEVICES. THE INVESTIGATION RESULTS CONCLUDE THE STAFF CAPPED OFF THE VENTILATOR CIRCUIT WITHOUT SWITCHING OFF THE NITRIC OXIDE, THEREBY, CAUSING A BUILD UP OF NITRIC OXIDE RESULTING IN INOVENT SHUT DOWN. THE INCIDENT IS CLOSED BASED ON THE FOLLOWING RATIONALE: THE INCIDENT WAS CAUSED BY A USER ERROR. FOLLOW-UP ACTION INCLUDES USER TRAINING.

    Description of Event or Problem · 1

    A BABY (GENDER, AGE UNSPECIFIED), WAS STARTED ON (B) (4) OF INOMAX ON (B) (6) 2010, FOR THE TREATMENT OF PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN). INOVENT (B) (4) WAS USED IN CONJUNCTION WITH A STEPHANIE VENTILATOR. ON (B) (6) 2010, THE BABY WAS DISCONNECTED FROM THE VENTILATOR CIRCUIT FOR A MEDICAL PROCEDURE. WHEN THE BABY WAS PUT BACK ON THE VENTILATOR, THE INOVENT ALARMED AND WENT INTO ELECTRONIC SHUTDOWN. THE STAFF THEN BAGGED THE BABY WITH NITRIC OXIDE WHILE INOTHERAPEUTICS WAS CONTACTED AND TROUBLESHOOTED THROUGH REBOOTING THE SYSTEM. THE BABY'S OXYGEN SATURATION DROPPED FROM THE 80S TO THE 60S. THE STAFF WAS TALKED THROUGH VARIOUS CALIBRATION PROCEDURES, CHANGED THE MONITORING LINE, AND AFTER 5 TO 7 MINUTES, THE MEASURED NITRIC OXIDE LEVEL READ ACCURATELY VERSUS SET NITRIC OXIDE. THE STAFF ENSURED THE LEVELS WERE STABLE FOR 5 MINUTES THEN PUT THE BABY BACK INTO THE CIRCUIT. THE BABY'S OXYGEN SATURATION THEN WENT BACK UP TO THE PREVIOUS LEVEL AND THE OXYGEN SATURATION DECREASE RESOLVED. THE BABY WAS DISCONTINUED FROM THE INOVENT 12 HOURS LATER, AND IT IS ASSUMPTION THE BABY WAS WEANED OFF OF INOMAX. THE BABY DIED LATER THE SAME DAY FROM A FULLY EXPECTED EVENT. THE CAUSE OF DEATH WAS PULMONARY HYPOPLASIA AND BILATERAL PLEURAL EFFUSIONS. THE REPORTER DEEMS THE DEATH NOT RELATED TO THE USE OF INOMAX.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O