BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2222550 · Received August 11, 2011

    Report

    Report Number
    3004531588-2011-00033
    Event Type
    Other
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 11, 2011
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4), 2011 AN IKARIA CLINICAL SPECIALIST CALLED IKARIA CUSTOMER SERVICE TO REPORT A PROBLEM WITH REGULATOR (B)(4) AND CYLINDERS (B)(4) AND DL (B)(4) ON THE INOMAXDS ((B)(4)). A RESPIRATORY THERAPIST CONFIRMED THAT THE REGULATOR WAS LEAKING AND PREMATURELY EMPTIED 2 CYLINDERS BEING USED TO ADMINISTER INOMAX THERAPY DURING TRANSPORT. TECHNICAL SUPPORT WAS ABLE TO SUCCESSFULLY TROUBLESHOOT THE DEVICE VIA TELEPHONE CONTACT, CONFIRMING A LEAK. LEAK. EVALUATION SUMMARY: DURING TELEPHONE TROUBLESHOOTING, THE REGULATOR WAS FOUND TO HAVE A LEAK AT THE THREAD RING WHICH SEALS THE END OF THE REGULATOR BODY. THE LEAK RESULTED FROM THE THREADED RING BEING LOOSENED, A CONDITION THAT HAD TO HAVE BEEN CAUSED BY THE APPLICATION OF COUNTER-CLOCKWISE TORQUE TO IT. IT IS UNKNOWN HOW THE THREADED RING WAS LOOSENED. THE DEVICE WAS RETURNED FOR FURTHER INVESTIGATION. INOMAX DS DEVICE LABELING INSTRUCTS THE USER TO PERFORM A PRE-USE CHECKOUT WHICH WOULD HAVE DETECTED A LEAK OF THIS KIND. THE PRE-USE CHECKOUT WAS NOT PERFORMED. THE ROOT CAUSE FOR THIS INCIDENT WAS USER ERROR IN NOT FOLLOWING INSTRUCTIONS CONTAINED IN THE LABELING. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011 AN IKARIA CLINICAL SPECIALIST CALLED IKARIA CUSTOMER SERVICE TO REPORT A PROBLEM A CUSTOMER ENCOUNTERED WITH REGULATOR (B)(4) AND CYLINDERS (B)(4) AND (B)(4) ON THE INOMAXDS ((B)(4)). A RESPIRATORY THERAPIST CONFIRMED THAT THE REGULATOR WAS LEAKING AND PREMATURELY EMPTIED 2 CYLINDERS BEING USED TO ADMINISTER INOMAX THERAPY DURING TRANSPORT. A PRETERM (B)(6) MALE (B)(6), WAS BEING PREPARED FOR TRANSPORT TO ANOTHER HOSPITAL FOR INOMAX THERAPY DUE TO HYPOXEMIA. THE NEONATE WAS INTUBATED AND ON THE CROSSVENT 2I+ VENTILATOR AT 100% FRACTIONAL INSPIRED OXYGEN (FIO2). THE NEONATE'S OXYGEN SATURATION LEVEL WAS IN THE 50% RANGE ON FIO2 OF 100%. THE TRANSPORT TEAM STARTED INOMAX THERAPY PRE-TRANSPORT VIA THE INOMAX DS ((B)(4)) USING A FULL D SIZE CYLINDER (B)(4) AND TRANSPORT REGULATOR (B)(4). SHORTLY AFTER STARTING INOMAX AT 20 PARTS PER MILLION THE NEONATE'S OXYGEN SATURATION LEVEL INCREASED TO 90%. APPROXIMATELY TEN (10) MINUTES AFTER PLACING THE NEONATE ON THE INOMAX DS, THE DEVICE ALARMED LOW NO/N2 PRESSURE. THE CYLINDER PRESSURE READING APPARENTLY INDICATED THE CYLINDER WAS EMPTY, DESPITE THE CYLINDER BEING FULL AT THE BEGINNING OF THE TRANSPORT. THE TRANSPORT TEAM CONNECTED A SECOND CYLINDER (B)(4) WITH THE SAME REGULATOR. THE SECOND CYLINDER BEGAN TO LEAK FROM THE REGULATOR AND THE TRANSPORT TEAM DETERMINED THAT THEY MAY RUN OUT OF INOMAX DURING THE 15-18 MINUTE TRANSPORT. THE SITUATION WAS DISCUSSED WITH THE NEONATOLOGIST AND A DECISION WAS MADE TO TRANSPORT THE NEONATE AND HAVE A SECOND TRANSPORT VEHICLE MEET THE TRANSPORT TEAM ON ROUTE TO PROVIDE AN ADDITIONAL INOMAX CYLINDER TO CONTINUE THERAPY. THE SECOND CYLINDER, (B)(4), ALSO RAPIDLY EMPTIED LEAVING THE NEONATE OFF INOMAX THERAPY FOR APPROXIMATELY 10-12 MINUTES DURING WHICH TIME HIS OXYGEN SATURATION LEVEL SLOWLY DECREASED FROM 90% DOWN TO 87%. DURING TRANSPORT, WHEN THE THIRD CYLINDER WAS CONNECTED TO THE INOMAX DS THE NEONATE'S OXYGEN SATURATION IMMEDIATELY WENT UP TO 98%. THE NEONATE ARRIVED AT THE RECEIVING HOSPITAL ON INOMAX THERAPY IN STABLE CONDITION WITH OXYGEN SATURATION LEVELS IN THE 98% RANGE AND WAS TRANSPORTED TO THE NEONATAL INTENSIVE CARE UNIT. IN THE REPORTER'S OPINION THE OXYGEN DESATURATION FROM 90% TO 87%, WHICH OCCURRED SLOWLY OVER SEVERAL MINUTES WAS MILD AND RELATED TO INTERRUPTION OF INOMAX THERAPY DUE TO A LEAKING REGULATOR. THERE WAS NO PROBLEM WITH THE INOMAX DS DEVICE. THE CYLINDERS AND REGULATOR ARE BEING RETURNED FOR INSPECTION. FOLLOWING COMPLETION OF THE TRANSPORT, TROUBLESHOOTING WAS PERFORMED ON SITE AT THE RECEIVING HOSPITAL BY THE IKARIA CLINICAL SPECIALIST REVEALING A RAPID LEAK IN THE AREA OF REGULATOR (B)(4). THE CUSTOMER STATED HE DID NOT COMPLETE A LEAK TEST PRIOR TO INITIATION OF NO THERAPY WITH THE INOMAX DS AS INSTRUCTED IN THE OPERATION AND MAINTENANCE (O&M) MANUAL. DURING TROUBLESHOOTING, WHEN THE REGULATOR WAS ATTACHED TO A TEST CYLINDER AND THE CYLINDER VALVE WAS TURNED ON THEN OFF, THE RESIDUAL PRESSURE, AS INDICATED ON THE REGULATOR GAUGE, FELL FROM 2000 POUNDS PER SQUARE INCH (PSI) TO ZERO (0) PSI IN <1 TO 2 SECONDS. THE INOMAX DS DELIVERY SYSTEM FUNCTIONED AS EXPECTED, ALARMING TO ALERT THE END-USER TO THE SITUATION. THE LEAK WAS INAUDIBLE WITH BACKGROUND NOISE AND WAS CORRECTED BY TIGHTENING THE END-CAP ON REGULATOR.

    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 12 DA Other