BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 6345933 · Received February 21, 2017

    Report

    Report Number
    3004531588-2017-00012
    Event Type
    Death
    Date Received
    February 21, 2017
    Date of Event
    January 17, 2017
    Report Date
    February 21, 2017
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR (B)(4) WAS CREATED AS (B)(4). THE SERVICE LOG WAS REVIEWED BY THE ENGINEERING TEAM AT MALLINCKRODT PHARMACEUTICALS. THE PHYSICAL DEVICE NOR THE ORIGINAL TEXT FILE SERVICE LOG WAS RETURNED TO THE MANUFACTURER FOR A COMPLETE INVESTIGATION. SERVICE LOG REVIEW REVEALS A DELIVERY FAILURE (DF) ALARM DUE TO CALCULATED OVER-DELIVERY. THE DF EVENT STOPS THE FLOW OF NO THERAPY PER SYSTEM DESIGN. FURTHER LOG ANALYSIS REVEALS THE DEVICE HAD BEEN RUNNING FINE FOR ~26 HOURS PRIOR TO THE DF. UNFORTUNATELY, THE SERVICE LOG HAD TURNED OVER IN PRECEDING SEQUENCE 148B, SO THE LOG DOES NOT CONTAIN MUCH PRE-EVENT HISTORY. THERE ARE NO USER CALIBRATIONS IN THE PROVIDED LOG PRIOR TO OR FOLLOWING THE DF EVENT, CONSISTENT WITH USE ERROR. HOWEVER, IT IS UNLIKELY USE ERROR CONTRIBUTED TO THE OVER-DELIVERY CONDITION AND ULTIMATELY THE DF ALARM AND THE STOPPAGE OF THE FLOW OF NO. SEQUENCE 149B CONTINUES AFTER THE DF EVENT FOR ANOTHER 30 MINUTES, AND THE COMPLAINT STATES THEY USED THE INOBLENDER, NOT BACKUP. THE USE OF THE INOBLENDER IS NOT CAPTURED IN THE SERVICE LOG. SERVICE WAS PROVIDED FOR THE DEVICE BY THE CUSTOMER'S SERVICE PROVIDER WHO REPORTED A PERFORMANCE CHECK VERIFIED BACK UP AND BLENDER OPERATION ARE WORKING INSIDE PARAMETERS. HOWEVER, THEY NOTED THE INJECTOR MODULE THAT WAS CONNECTED DURING THE FAILURE PASSED THE PERFORMANCE TEST AT 10 PPM (READING: 7.5 PPM) BUT FAILS THE PERFORMANCE TEST AT 40 PPM (READING: 30 PPM). THE CUSTOMER REPORTS THAT WHILE USING ANOTHER INJECTOR MODULE, THE DEVICE PASSED THE PERFORMANCE CHECK. HOWEVER, AN INJECTOR MODULE THAT IS NOT PROPERLY REPORTING FLOW CANNOT CAUSE OVER-DELIVERY. THE ROOT CAUSE FOR OVER-DELIVERY IS A PROPORTIONAL VALVE THAT IS NOT RESPONDING CORRECTLY. GUIDANCE TO REPLACE THE PROPORTIONAL VALVE WAS PROVIDED TO THE CUSTOMER'S SERVICE PROVIDER. THE ROOT CAUSE FOR THIS REPORT IS DUE PROPORTIONAL VALVE FAILURE. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER THE COMPANY'S QUALITY SYSTEM.

    Description of Event or Problem · 1

    ON 23-JAN-2017, A CIOMS FORM WAS REPORTED TO MALLINCKRODT PHARMACEUTICALS REPORTING A DELIVERY FAILURE ALARM AND A POTENTIAL ADVERSE EVENT ON INOMAX DSIR (B)(4). THE REPORT ADDRESSES A COMPLICATED COURSE FOR A (B)(6) NEONATE IN (B)(6) WITH CONGENITAL HEART DISEASE. THE NEONATE WAS HAVING CARDIAC SURGERY AND WAS ON INHALED NITRIC OXIDE THERAPY AFTER SURGERY. AFTER ABOUT 26 HOURS ON INHALED NITRIC OXIDE (10 PPM) THERE WAS A DEVICE ISSUE HANDLED IN ACCORDANCE TO SMPC AND IFU WITH USE OF THE BACK-UP DOSING DEVICE. IN ASSOCIATION TO THE DEVICE ISSUE THE NEONATE HAD A CARDIOVASCULAR COLLAPSE, CARDIAC ARREST. THE CIRCULATION WAS RESTORED AND THE NEONATE WAS PUT BACK ON A BACK-UP INHALED NITRIC OXIDE MACHINE. IT IS NOT POSSIBLE TO RULE OUT A POSSIBLE ASSOCIATION BETWEEN THE DEVICE ISSUE AND NEED FOR SWITCH TO BACK-UP DOSING AND THE CARDIOVASCULAR COLLAPSE. THE NEONATE IS OF COURSE MOST FRAGILE AND HAD UNDERGONE CARDIAC SURGERY THUS THE CARDIAC EVENT MAY HAVE BEEN SOLELY AN EFFECT OF THE DISEASE COURSE. THE NEONATE DIED LATER ON THE DAY OF THE EVENT, THE DEATH WAS ASSESSED BY THE ATTENDING PHYSICIAN AS UNRELATED TO THE DEVICE ISSUE AND CARDIOVASCULAR EVENT. THUS "REBOUND CARDIOVASCULAR COLLAPSE" CAUSED BY THE DEVICE ISSUE CANNOT BE RULED OUT. NEONATE SUBSEQUENTLY DIED LATER DUE TO DISEASE PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128101 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10051

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death| O