BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3131107 · Received May 23, 2013

    Report

    Report Number
    3004531588-2013-00013
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INOMAX DSIR DEVICE DS20100298 IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE WENT INTO DELIVERY FAILURE AFTER BEING CONNECTED TO PATIENT [DEVICE ISSUE]. CARDIAC ARREST [CARDIAC ARREST]. VENTRICULAR FIBRILLATION [VENTRICULAR FIBRILLATION]. BLOOD PRESSURE DECREASED [BLOOD PRESSURE DECREASED]. OXYGEN SATURATION DECREASED [OXYGEN SATURATION DECREASED]. CASE DESCRIPTION: THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES. THE RT CALLED IKARIA TO REPORT A DELIVERY FAILURE WITH THE INOMAX DSIR DS20100298 WHILE ON A PATIENT WHO "CODED". ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 IS INCLUDED IN THIS REPORT. RELEVANT MEDICAL HISTORY INCLUDES: (B)(6) MALE, "EXTENSIVE CARDIAC HISTORY", PREVIOUS OPEN HEART SURGERY, PREVIOUSLY PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AND INTRA-AORTIC BALLOON PUMP (IABP) PLACEMENT. CONCOMITANT MEDICATIONS NOT PROVIDED. THIS CRITICALLY ILL PATIENT WAS STARTED ON INOMAX VIA THE INOMAX DSIR DS 20100298 AT 40 PARTS PER MILLION (PPM) ON (B)(6) 2013 AT 13:15. ON THE MORNING OF (B)(6) 2013, DURING THE RT SUPERVISOR'S ROUNDS, SHE NOTICED THE INOMAX DSIR DS20100298 WAS SET AT 40 PPM NITRIC OXIDE (NO) AND MONITORING 58 PPM. SHE DID A LOW CALIBRATION WHICH CORRECTED THE PROBLEM. LATER THAT DAY, THE PATIENT WENT TO THE OPERATING ROOM FOR OPEN HEART SURGERY AND REMOVAL OF AN INTRA-AORTIC BALLOON. THE DSIR DEVICE ACCOMPANIED THE PATIENT TO THE OPERATING ROOM AND FUNCTIONED WITHOUT PROBLEMS. POST-OPERATIVELY, WHILE BEING TRANSPORTED TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT WAS MANUALLY VENTILATED WITH THE INOBLENDER SET AT 40 PPM OF INOMAX AND OXYGEN 100%. UPON ARRIVAL IN THE ICU, A DRAGER VENTILATOR WAS SET UP AS FOLLOWS: ASSIST CONTROL 20, TIDAL VOLUME 300ML, FIO2 100%, AND POSITIVE END EXPIRATORY PRESSURE (PEEP) +10 CM H2O. THE DSIR'S INJECTOR MODULE WAS PLACED IN THE VENTILATOR CIRCUIT AND THE PATIENT WAS CONNECTED TO THERAPY. IMMEDIATELY FOLLOWING CONNECTION, THE INOMAX DSIR ALARMED DELIVERY FAILURE. SIMULTANEOUSLY, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND "CODED" WITH DECREASE IN BLOOD PRESSURE AND OXYGEN DESATURATION (BASELINE PARAMETERS FOR BP AND SPO2 NOT PROVIDED). THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED WITH THE INOBLENDER. CARDIO PULMONARY RESUSCITATION WAS STARTED, MEDICATIONS WERE ADMINISTERED (TYPES AND DOSAGES NOT PROVIDED) AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE RT CONTINUED TO MANUALLY VENTILATE THE PATIENT WHILE THE DSIR WAS SWITCHED OUT. THE PATIENT WAS RE-CONNECTED TO THE VENTILATOR AND NEW DSIR WHICH FUNCTIONED WITHOUT FURTHER PROBLEMS. THE RT STATED THAT AFTER THE DSIR WAS REMOVED FROM THE PATIENT, SHE DID "A CHECK OF THE DEVICE AND IT PASSED THE TEST". THE DEVICE WAS RETURNED TO IKARIA FOR INSPECTION. THE RT STATED THAT THE PHYSICIAN AT THE PATIENT'S BEDSIDE DID NOT FEEL THE DEVICE ISSUE HAD ANYTHING TO DO WITH THE PATIENT CODING. HOWEVER, NO ALTERNATIVE EXPLANTATION WAS PROVIDED. IN A FOLLOW UP PHONE CALL WITH IKARIA TECHNICAL SERVICES THE RT SUPERVISOR STATED THAT SHE BELIEVES THE DEVICE WENT INTO DELIVERY FAILURE BECAUSE THE DSIR WAS LEFT ON 40 PPM INSTEAD OF BEING TURNED TO ZERO DURING THE TRANSPORT. TS EXPLAINED THAT BY NOT TURNING THE DSIR TO ZERO WHILE USING THE NOBLENDER, NITRIC OXIDE BUILDS UP IN THE SYSTEM AND WHEN THE DEVICE IS RECONNECTED TO THE PATIENT, THE BUILDUP OF NO CAN CAUSE THE DEVICE TO ALARM DELIVERY FAILURE, PER DESIGN. THE RT REQUESTED ADDITIONAL STAFF TRAINING WHICH IS BEING ARRANGED. COMPANY COMMENT DATED (B)(4) 2013: WHILE THE TREATING PHYSICIAN DID NOT CONSIDER INTERRUPTION OF THERAPY TO BE THE UNDERLYING ETIOLOGY OF THE PATIENT'S VENTRICULAR FIBRILLATION AND CARDIAC ARREST, CONSIDERING THE SEQUENCE OF EVENTS, THE COMPANY CANNOT EXCLUDE A CAUSAL RELATIONSHIP. THE PATIENT'S FRAGILE STATE, SIGNIFICANT CARDIAC HISTORY AND RECENT CARDIAC SURGERY DO HOWEVER OFFER LIKELY ALTERNATIVE EXPLANTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229591 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIS OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| O