BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX, DSIR (DELIVERY SYSTEM)

    MDR report key: 3165153 · Received June 10, 2013

    Report

    Report Number
    3004531588-2013-00014
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 12, 2013
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, A LEAD RT CALLED IKARIA CUSTOMER CARE TO REQUEST TECHNICAL SUPPORT FOR A DELIVERY FAILURE ALARM WITH THE INOMAX DSIR (B)(4) WHILE IN USE ON A PT. (B)(4). EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MFR FOR SERVICE INVESTIGATION. EVAL OF THE SERVICE LOG REVEALED A FAILURE IN A ROUTINE OXYGEN CELL LOW CALIBRATION PERFORMED BY THE USER PRIOR TO THE DELIVERY FAILURE THAT WAS REPORTED BY THE HOSPITAL. THIS OXYGEN SENSOR CALIBRATION FAILURE WAS CAUSED BY ADC COUNTS EXCEEDING 4095 WHICH IS INDICATIVE OF AN ELECTRICAL OVERCURRENT CONDITION FROM THE OXYGEN SENSOR. THIS ISSUE CAUSED CONVERSION ERRORS IN THE NO SENSOR INPUT TO THE MONITORING SYSTEM CIRCUIT BOARD WHICH IN TURN CAUSED ERRONEOUSLY HIGH MONITORED NO READINGS AND ULTIMATELY RESULTED IN THE TRIGGERING OF THE HIGH NO CONCENTRATION ALARM AND INTERRUPTION OF NO DELIVERY. THE OXYGEN SENSOR WAS REPLACED TO ADDRESS THE ISSUE OF THE HIGH OXYGEN SENSOR ADC ACCOUNTS OBSERVED IN THE LOG. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. IT SHOULD BE NOTED THAT THE SERVICE LOG REVEALED THAT THE USER DID NOT PERFORM A PRE-USE CHECKOUT ON THE DEVICE PRIOR TO INITIATION OF TREATMENT TO THE PT AS IS INDICATED IN THE DEVICE LABELING. HAD THE PRE-USE CHECKOUT BEEN PERFORMED, THE DELIVERY FAILURE MAY HAVE BEEN DETECTED AND THE DEVICE REMOVED FROM SERVICE PRIOR TO BEING USED TO TREAT THE PT. THE MONITORING SYSTEM ON THE INOMAX DSIR IS SEPARATED FROM THE DELIVERY SYSTEM SO THE ERRONEOUS MONITORED NO READINGS DO NOT AFFECT THE CONCENTRATION OF NO DELIVERED BY THE DEVICE. WHEN THIS ISSUE OCCURS, THE EFFECT ON THE DELIVERY SYSTEM IS TO TRIGGER AN ALARM AND INTERRUPT DELIVERY ONLY IF THE MONITORED NO CONCENTRATION VALUES EXCEED 100 PPM. SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED AND IKARIA WILL CONTINUE TO FOLLOW ESTABLISHED PROCEDURES TO MONITOR, IDENTIFY AND ADDRESS ANY FURTHER REQUIRED ACTIONS. THE ROOT CAUSE FOR THIS INCIDENT WAS A MALFUNCTION OF THE OXYGEN SENSOR INSTALLED IN THE DEVICE. COMPANY COMMENT DATED (B)(4) 2013: ALTHOUGH THE DELIVERY FAILURES DESCRIBED IN THIS CASE WERE NOT ASSOCIATED WITH SERIOUS INJURIES, SERIOUS ADVERSE EVENTS OR DEATH, UNDER LESS FORTUNATE CIRCUMSTANCES, THESE FAILURES COULD RESULT IN SUCH SERIOUS COMPLICATIONS.

    Description of Event or Problem · 1

    DSIR WENT INTO DELIVERY FAILURE AFTER REPEATING LOW CALIBRATION FOR MONITORED NO OF 97 PPM [DEVICE MALFUNCTION]. DELIVERY FAILURE AFTER MONITORED NO READING WENT TO 86 PPM [DEVICE MALFUNCTION]. DEVICE ALARMED DELIVERY FAILURE AFTER MONITORED NO READING WAS 86 PPM [DEVICE MALFUNCTION]. DEVICE WENT TO DELIVERY FAILURE [DEVICE MALFUNCTION]. BABY DESATURATED [OXYGEN SATURATION DECREASED]. CASE DESCRIPTION: THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A LEAD RESPIRATORY THERAPIST (LRT) IN THE UNITED STATES. THE LRT CALLED IKARIA CUSTOMER CARE TO REQUEST TECHNICAL SUPPORT FOR A DELIVERY FAILURE ALARM WITH THE INOMAX DSIR (B)(4) WHILE IN USE ON A PT. THE LRT STATED TO TECHNICAL SERVICES THAT THE "PT HAD TO BE MANUALLY VENTILATED AND THE PT'S [OXYGEN] SATURATIONS DROPPED FROM 91% TO 86% DURING MANUAL VENTILATION". ADD'L INFO RECEIVED ON (B)(6) 2013 IS INCLUDED IN THIS REPORT. RELEVANT MEDICAL HISTORY/COMORBIDITIES INCLUDED: A PREMATURE MALE INFANT BORN ON (B)(6) 2013 AND (B)(6) GESTATION, INTUBATED AND ON 100% OXYGEN WITH POOR OXYGENATION AND PULMONARY INTERSTITIAL EMPHYSEMA (P.I.E.). ACCORDING THE LEAD RT (LRT), THE NEONATE WAS ON THE SENSORMEDICS 3100A OSCILLATORY VENTILATOR WITH THE FOLLOWING SETTINGS (START DATE NOS): FREQUENCY 15 HERTZ (HZ), AMPLITUDE (AMP) 48, FLOW 20, MEAN AIRWAY PRESSURE (MAP) 9 CM H2O AND FRACTIONAL INSPIRED OXYGEN CONCENTRATION (FIO2) OF 100%. ON (B)(6) 2013, DUE TO "POOR OXYGENATION", THE NEONATE WAS STARTED ON INOMAX AT 20 PARTS PER MILLION (PPM) VIA INOMAX DSIR (B)(4). THE NEONATE'S BASELINE OXYGEN SATURATION LEVELS ON THOSE SETTINGS WERE IN THE MID TO UPPER 90% RANGE. ON (B)(6) 2013, WHILE PREPARING TO DRAW A BLOOD GAS, THE BESIDE RT OBSERVED THAT INOMAX DSIR (B)(4) WAS REPORTEDLY MONITORING A NITRIC OXIDE (NO) VALUE OF 97 PPM. THE RT ATTEMPTED TO CORRECT THE MEASURED NO VALUE GREATER THAN SET NO (20 PPM) BY PERFORMING A LOW CALIBRATION AND REPLACING THE DISPOSABLES. ACCORDING TO THE LRT, THE BESIDE RT WAS UNDER THE IMPRESSION THAT WHEN PERFORMING A LOW CALIBRATION REMOVAL OF THE SAMPLE LINE FROM THE CIRCUIT WAS NECESSARY. AFTER COMPLETING THE LOW CALIBRATION THE SAMPLE LINE WAS THEN RECONNECTED TO THE OSCILLATOR CIRCUIT AND A DELIVERY FAILURE OCCURRED. WITH THE BACKUP SWITCH IN THE OFF POSITION, THE RT POWERED THE DEVICE OFF AND THEN BACK ON. DURING THE TROUBLESHOOTING BY THE RT, THE PT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED BY THE NURSE, WITH THE INOBLENDER SET AT 20 PPM AND 100% OXYGEN. WHEN THE NURSE STARTED BAGGING, THE PT'S O2 SATURATION BEGAN TO DECREASE FROM 91% TO 86% BUT WITHIN 1 MINUTE RETURNED TO BASELINE. THE LRT WAS CALLED TO THE BEDSIDE AND IKARIA TECHNICAL SUPPORT WAS CONTACTED FOR ASSISTANCE. THE IKARIA TECHNICAL SUPPORT REP EXPLANTED TO THE LRT THAT REMOVAL OF THE SAMPLE LINE DURING A LOW RANGE CALIBRATION IS NEITHER NECESSARY NOR RECOMMENDED AND THAT THE ZERO VALVE ALLOWS THE GAS SENSORS TO BE ZEROED DURING LOW CALIBRATION WITHOUT HAVING TO DISCONNECT THE SAMPLE LINE FROM THE BREATHING CIRCUIT. THE LRT STATED THAT HE FELT THE DELIVERY FAILURE WAS DUE TO A MISUNDERSTANDING BY THE BEDSIDE RT ON HOW TO PERFORM A LOW CALIBRATION AND THEREFORE, REFUSED TO REMOVE THE DEVICE FROM THE PT DESPITE A REQUEST BY IKARIA TECHNICAL SUPPORT TO RETURN THE DEVICE FOR INSPECTION. ABOUT 10 - 15 MINUTES AFTER INOMAX DSIR DEVICE (B)(4) WAS PLACED BACK ON THE PT, THE MONITORED NO READING WENT TO 86 PPM AND THE DEVICE WENT INTO DELIVERY FAILURE. THE RT, RN AND MD WERE IN THE ROOM AND THE INFANT WAS IMMEDIATELY REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED WITH THE INOBLENDER. THE PT'S OXYGEN SATURATION REMAINED STABLE DURING MANUAL VENTILATOR. THE LRT TURNED THE DEVICE OFF, THEN BACK ON, AND A LOW CALIBRATION WAS PERFORMED. THE DEVICE AGAIN APPEARED TO BE WORKING FINE, AND THE DECISION WAS MADE TO KEEP INOMAX DSIR (B)(4) IN USE ON THE PT. APPROX 1 1/2 HOURS LATER, THE NURSE SUCTIONED AND REPOSITIONED THE PT, AFTER WHICH THE BEDSIDE RT OBSERVED THAT THE MONITORED NO READING WAS 86 PPM AND THE DEVICE ALARMED DELIVERY FAILURE. THE PT WAS IMMEDIATELY REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED WITH THE INOBLENDER WHILE THE RT TROUBLESHOOT THE DEVICE. THE PT'S OXYGEN SATURATION LEVELS REMAINED STABLE. THE RT FELT THAT THE DELIVERY FAILURE WAS CAUSED BY SUCTIONING AND REPOSITIONING THE PT AND THEREFORE, DECIDED TO LEAVE THE PT ON THE DEVICE. DURING THE NIGHT SHIFT ON (B)(6) 2013, AN RT OBSERVED THAT THE MONITORED NO ON INOMAX DSIR (B)(4) SPIKED AND THEN SLOWING RETURNED TO 20 PPM. THERE WAS NO IMPACT TO THE PT TO THE PT AND THE BEDSIDE RT SUCCESSFULLY TROUBLESHOOT THE DEVICE. LATER IN THE SHIFT, THE DEVICE WENT INTO DELIVERY FAILURE AND THE RT DECIDED TO SWITCH OUT DEVICES AND REMOVE INOMAX DSIR (B)(4) FROM SERVICE. THE INFANT WAS REMOVED FROM THE VENTILATOR AND "BAGGED WITH THE INOBLENDER" WHILE THE DEVICE WAS SWITCHED OUT. THERE WAS NO HARM TO THE PT AND THERE WAS NO OXYGEN DESATURATIONS THAT OCCURRED DURING BAGGING AND SWITCH OUT OF DEVICES. THE LEAD RT CONSIDERED THE EPISODE OF OXYGEN DESATURATION ON (B)(6) 2013 TO BE BRIEF AND NON-SERIOUS IN NATURE AND AT THE TIME CONSIDERED IT TO BE DUE TO A MISUNDERSTANDING BY THE BEDSIDE RT ON HOW TO PERFORM A LOW CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261437 INOMAX, DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC, OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DA Other