BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2324813 · Received November 2, 2011

    Report

    Report Number
    3004531588-2011-00040
    Event Type
    Injury
    Date Received
    November 2, 2011
    Date of Event
    October 5, 2011
    Report Date
    November 2, 2011
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2011, A RESPIRATORY CARE SPECIALIST (RCP) REPORTED THAT INOMAX DS DEVICE #(B)(4) ALARMED DELIVERY FAILURE WHILE ON A PT ((B)(4)). EXAMINATION OF THE INOMAX DS SERVICE LOG CONFIRMED A DELIVERY FAILURE ALARM DUE TO UNDER-DELIVERY OF NITRIC OXIDE. ACCORDING TO (B)(6) REPORTER THE VENTILATOR CIRCUIT BECAME ABRUPTLY DISCONNECTED WHILE TRANSFERRING THE PT FROM ONE BED TO ANOTHER. ABRUPT DISCONNECTION OF THE VENTILATOR CIRCUIT, IN SOME VENTILATOR MODES, IS KNOWN TO CAUSE EXCESSIVE FLOW RATES THROUGH THE VENTILATOR CIRCUIT AND THE INJECTOR MODULE OF THE INOMAX DS, OUTSIDE THE LABELED SPECS FOR THE INOMAX DS DEVICE. FLOW RATES ABOVE 120 LPM MAY RESULT IN THE CALCULATED NO DELIVERY BEING LESS THAN HALF THE SET DOSE, THUS BY DESIGN, THE DEVICE ALARMS AND DISPLAYS A DELIVERY FAILURE FOR UNDER DELIVERY OF NITRIC OXIDE. THE REPORTER NOTED THE INJECTOR MODULE FAILURE WAS DISCOVERED AFTER THE DEVICE HAD BEEN REMOVED FROM THE PT WHILE THE REPORTER WAS TROUBLESHOOTING THE DEVICE AND IS UNRELATED TO THE REPORTED DELIVERY FAILURE. THE ROOT CAUSE OF THE REPORTED INCIDENT WAS USER ERROR ASSOCIATED WITH OPENING THE VENTILATOR CIRCUIT LEADING TO AN OUT OF SPEC VENTILATOR FLOW RATE, RESULTING IN UNDER-DELIVERY OF NITRIC OXIDE, WHICH WAS DETECTED BY THE INOMAX DS, WHICH ALARMED AND WENT INTO DELIVERY FAILURE, AS DESIGNED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPIRATORY CARE SPECIALIST (RCP) REPORTED THAT INOMAX DS DEVICE #(B)(4) ALARMED DELIVERY FAILURE WHILE ON A PT. A (B)(6) ADULT FEMALE, WITH LEUKEMIA AND BEING CARED FOR IN THE INTENSIVE CARE UNIT, WAS INTUBATED AND ON A PRESSURE CONTROLLED VENTILATOR (SETTINGS: PRESSURE 27; RATE 20; I:E 2:1; PEEP 15) WITH FRACTION OF INSPIRED OXYGEN OF 1.0. THE PT WAS HEMODYNAMICALLY UNSTABLE AND HER OXYGEN SATURATION LEVELS RANGED FROM THE "TEENS" TO A MAXIMUM OF 40%. SHE WAS RECEIVING MULTIPLE UNSPECIFIED MEDICATIONS. ON (B)(6) 2011, THE DECISION WAS MADE TO INITIATE TREATMENT WITH INOMAX AT 80 PARTS PER MILLION (PPM) VIA INOMAX DS DEVICE #(B)(4), AND AT APPROX 15:30 THE PT'S OXYGEN SATURATION WAS NOTED TO HAVE INCREASED TO THE 70'S. ABOUT ONE HOUR LATER, THE PT WAS MOVED FROM A REGULAR BED TO A "PRONING BED" (WHICH SLOWLY ROTATED THE PT), AND DURING THE TRANSFER THE METERED-DOSE-INHALER (MDI) ADAPTER KEPT POPPING OFF, "BREAKING THE CIRCUIT", AND FINALLY HAD TO BE SECURED WITH TAPE. AT ABOUT THIS SAME TIME, THE INOMAX DS DEVICE ALARMED "NITRIC OXIDE FAILURE OR NITRIC OXIDE DELIVERY FAILURE". THE RCP THEN REPEATEDLY FLIPPED THE BACK-UP SWITCH ON AND OFF TO TRY TO CLEAR THE DELIVERY FAILURE, BUT WHEN THE DELIVERY FAILURE DIDN'T CLEAR, THE DECISION WAS MADE TO SWITCH TO A REPLACEMENT DEVICE. THE PT'S OXYGEN SATURATION WAS NOTED TO HAVE DECREASED TO THE 50'S, AND AFTER THE PT WAS SWITCHED TO THE REPLACEMENT DEVICE IT "SLOWLY INCREASED". THE RCP ESTIMATED THAT IT TOOK APPROX 15-20 MINUTES TO SWITCH OUT THE DEVICE, AND HOURS LATER, HER OXYGEN SATURATION WAS NOTED TO BE BETWEEN 96-97%. WHEN THE RCP CONTACTED IKARIA ON (B)(6) 2011 REGARDING THE DELIVERY FAILURE WHICH HAD OCCURRED ON THE PREVIOUS DAY, IKARIA TECHNICAL SUPPORT ADVISED THE RCP THAT THE ONLY WAY TO CLEAR A DELIVERY FAILURE IS TO POWER THE DEVICE TO STANDBY AND THEN BACK ON. LATER IN THE DAY ON (B)(6), 2011, THE CIRCUIT WAS DISCONNECTED AGAIN, AND THE REPLACEMENT INOMAX DS DEVICE (# (B)(4)) ALARMED. THIS TIME, THE RCP POWERED THE DEVICE TO STANDBY AND THEN BACK ON, THE ALARM CLEARED AND THE DEVICE RESUMED DELIVERY OF THE NITRIC OXIDE. PRIOR TO "BREAKING THE CIRCUIT" THE PT'S OXYGEN SATURATION WAS NOTED TO BE IN THE LOW 90S. HER OXYGEN SATURATION LEVELS DIPPED TO 85-87% FOR LESS THAN ONE MINUTE WHILE THE INOMAX DS DEVICE ALARM WAS CLEARED. THE OXYGEN SATURATION DECREASE WAS CONSIDERED TO BE NON-SERIOUS. LATER THAT EVENING, THE DECISION WAS MADE TO WEAN THE PT'S NITRIC OXIDE DOSE TO 40 PPM, AND THE PT WAS NOTED TO HAVE A FEVER, REDUCED BLOOD PRESSURE (UNSPECIFIED), AND RESPIRATORY ACIDOSIS (PCO2 - 130). DURING THE NIGHT AND AT 08:00 TO 09:30 THE PT CODED THREE TIMES, AND DURING THAT TIME WAS MANUALLY VENTILATED USING THE INOBLENDER. AT 09:30 THE PHYSICIAN MADE THE DECISION TO DISCONTINUE TREATMENT WITH NITRIC OXIDE, AND AT 11:30 THE PT DIED FROM CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DS (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS, LLC/IKARIA 10003

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death| O