BEUDAMED
    FDA Adverse Event Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)/INOMAX DSIR CART (PN10018)

    MDR report key: 4375223 · Received December 2, 2014

    Report

    Report Number
    3004531588-2014-00073
    Date Received
    December 2, 2014
    Report Date
    November 3, 2014
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY AS PER IKARIA'S PRACTICE, THIS MANUFACTURER'S MDR IS BEING SUBMITTED IN RESPONSE TO THE RECEIPT OF A USER MDR FROM THE FDA. INOMAX DSIR #(B)(4) AND CART (CT20090483) WERE NOT PICKED UP AT TIME OF REPORTED EVENT. IKARIA QUALITY DID A SEARCH OF THE COMPLAINT DATABASE AND IN 2014 THERE WAS NO COMPLAINT RECEIVED FROM THIS FACILITY FOR THE DATES REPORTED IN THE USER MDR FOR THESE EVENTS. THE DSIR AND CART HAVE SINCE BEEN PICKED UP FOR PREVENTATIVE MAINTENANCE (PM). THE PM SERVICE DID NOT CONFIRM REPORTED ISSUES OF CYLINDER NOT DETECTED NOR CYLINDER VALVE CLOSED ALARMS. THE ROOT CAUSE FOR THIS INCIDENT WAS: REPORTED FAILURE NOT REPRODUCIBLE. COMPLAINT#(B)(4).

    Description of Event or Problem · 1

    DEVICE ALARMED "CYLINDER NOT DETECTED/VALVE CLOSED" [DEVICE ISSUE] OXYGEN DESATURATION FROM 92% TO 84% [OXYGEN SATURATION DECREASED] CASE DESCRIPTION: ON (B)(6) 2014, A MEDSUN SAFETY REPORT, USER FACILITY# (B)(4) WAS RECEIVED BY IKARIA FROM THE FDA. THE REPORT STATES THAT ON (B)(6) 2014 THAT THE INOVENT MACHINE (INOMAX DSIR# (B)(4)) ALARMED "CYLINDER NOT DETECTED/VALVE CLOSED" ((B)(4)) AND THE "NITRIC" WAS NOT DELIVERED TO THE PATIENT. THE PATIENT EXPERIENCED AN OXYGEN DESATURATION FROM 92% TO 84% FOR A LITTLE LESS THAN 5 MINUTES AND QUICKLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014 AND IS INCLUDED IN THIS REPORT. RELEVANT MEDICAL HISTORY/CO-MORBIDITIES: ARDS (INTERPRETED AS ACUTE RESPIRATORY DISTRESS SYNDROME), HYPOXIA, DKA (DIABETIC KETOACIDOSIS), WOUND GANGRENE OF R BIG TOE AREA, STATUS-POST RIGHT BIG TOE AMPUTATION, (B)(6) OF THE BLOOD AND RIGHT AMPUTATED BIG TOE AREA-ON ADMISSION, RESPIRATORY DISTRESS, VERY SICK, SEPSIS (ON VASOPRESSORS), INTUBATED (NOS) AND MECHANICAL VENTILATION (NOT SPECIFIED). RELEVANT CONCOMITANT MEDICATION: VASOPRESSORS (NOT SPECIFIED) ON (B)(6) 2014, A (B)(6) SEPTIC MALE ADULT, WHO WEIGHED 85 KILOGRAMS WAS A TRANSFERRED FROM ANOTHER FACILITY. THE PATIENT HAD A HISTORY OF A RIGHT BIG TOE AMPUTATION PRIOR TO ADMISSION AT CURRENT FACILITY ON AN UNSPECIFIED DATE; NO FURTHER DETAILS WERE PROVIDED. HE WAS ADMITTED ON THE SAME DAY WITH A DIAGNOSIS OF WOUND GANGRENE WITH (B)(6) OF THE R BIG TOE AMPUTATED AREA AND BLOOD. HE WAS REPORTED TO BE VERY SICK, ON VASOPRESSORS, AND INTUBATED WITH MECHANICAL VENTILATION (TYPE NOT SPECIFIED) DUE TO RESPIRATORY DISTRESS ON ADMISSION. UPON ADMISSION, SAO2 WAS AT 97% WITH NO VENTILATOR SETTINGS PROVIDED. AN ATTEMPT WAS MADE TO REMOVE THE PATIENT OFF THE VENTILATOR BUT HE BECAME HYPOXIC AND NEEDED TO BE PUT BACK ON THE VENTILATOR. VENTILATOR SETTINGS WERE REPORTED TO BE OF A LOW TIDAL VOLUME AND PLATEAU PRESSURES (BOTH NOT SPECIFIED). ON THE SAME DAY, LABS WERE ALSO COLLECTED WHICH SHOWED GLUCOSE 150 (UNITS NOT PROVIDED) WITH NEGATIVE KETONES. A CHEST X-RAY SHOWED NEAR OPACITY OF THE RIGHT LUNG AND MOSTLY OF LEFT LUNG EXCEPT FOR LEFT UPPER LOBE WHICH WAS OKAY. AN ECHOCARDIOGRAM WAS PERFORMED ON THIS DAY, AND SHOWED SOME PERICARDIA! EFFUSION WITHOUT VEGETATION OBSERVED. INOMAX WAS STARTED LATER SAME DAY (UNSPECIFIED DOSE OR START TIME), FOR LOW OXYGENATION, NO VALUES WERE SPECIFIED. THE PATIENT HAD STABLE VITAL SIGNS ON (B)(6) 2014 AT 02:20 BUT WAS "RETAINING CO2", NO FURTHER DETAILS WERE PROVIDED. CARDIOLOGY, INFECTIOUS DISEASE AND PULMONARY CONSULTS WERE COMPLETED BUT NO FURTHER DETAILS WERE PROVIDED. ON THE SAME DAY, THE PATIENT DEVELOPED "HEMATOCHEZIA" DURING THE NIGHT; NO FURTHER DETAILS WERE PROVIDED. NO INFORMATION WAS PROVIDED IF INOMAX WAS ONGOING OR STOPPED ON THIS DAY. ON THE NEXT DAY, (B)(6) 2014 AT 04:47, ARTERIAL BLOOD GASES WERE DRAWN AND RESULTS WERE REPORTED AS "WORSE", WITH NO SPECIFICS PROVIDED. INOMAX WAS REPORTED TO BE STARTED, AT A DOSE AND TIME, NOT SPECIFIED. THE RT STATED THAT THE PATIENT WAS ON INOMAX AT 10:00, NO FURTHER DETAILS WERE PROVIDED. ON (B)(6) 2014, THE PATIENT WAS ON INOMAX AND THAT HIS ARTERIAL BLOOD GASES "RESPONDED TO THE NO", NO FURTHER DETAILS WERE PROVIDED. ON (B)(6) 2014, AT 11:00, DSIR #(B)(4) ON CART ((B)(4)) REPORTED (ALARMED) "CYLINDER NOT DETECTED WITH VALVE CLOSED". THE RT EXPLAINED THAT THE PATIENT EXPERIENCED A PULSE OXIMETRY DROP FROM 92% TO 84% FOR A LITTLE LESS THAN 5 MINUTES AND QUICKLY RECOVERED, NO BRADYCARDIA OR HYPOTENSION OCCURRED DURING THE OXYGEN DESATURATION EVENT. THE RT WAS NOT SURE IF THE INOBLENDER WAS USED DURING THE DEVICE ISSUE. THE DSIR# (B)(4) WAS SWITCHED OUT. ON (B)(4) 2014, THE PATIENT RECEIVED INOMAX, NO FURTHER DETAILS WERE PROVIDED. ABG'S WERE COMPLETED ON (B)(6) 2014 AND SHOWED A PH- 7.27; PCO2- 83; P02- 60; HCO3- 33 WITH VENT SETTINGS OF FIO2- 100%, PRESSURE SUPPORT (PS)- 34/8, AND RESPIRATORY RATE (RR) - 26. THE RT STATED THAT THE PATIENT WAS PLACED ON "COMFORT CARE", EXTUBATED WITH FAMILY CONSENT AND THEN PASSED AWAY ON (B)(6) 2014 AT 14:30. THE RT WAS NOT SURE IF THE PATIENT DIED WHILE ON INOMAX AND THE MEDICAL RECORDS DID NOT MENTION INOMAX ON THIS DATE. IT WAS REPORTED THAT THE CURRENT FACILITIES BIO-MEDICAL DEPARTMENT ATTEMPTED TO DUPLICATE THE DSIR DEVICE ISSUE ON (B)(6)2014 WITHOUT SUCCESS. ALL CALIBRATIONS WERE PERFORMED AND ALL PASSED. IN THE OPINION OF THE RT, THE PATIENT'S OXYGEN DESATURATION WAS DUE TO "INOMAX" AND THE INOMAX DSIR DELIVERY ISSUE. EVEN THOUGH THE SITE REPORTED THE DEVICE USED ON THE PATIENT AS INOVENT, THE ACTUAL DEVICE USED ON THE PATIENT WAS DSIR. OF NOTE, INOVENT DEVICES WERE ALL COMMERCIALLY REPLACED WITH INOMAX DSIR BY (B)(6) 2013. CASE COMMENT: (B)(6)2014: THIS IS A POST-MARKETING SPONTANEOUS DEVICE REPORT RECEIVED AS A MEDSUN SAFETY REPORT FROM FDA. THE MANUFACTURER AGREES WITH THE REPORTER THAT THE EVENT IS RELATED TO THE DEVICE AS THE EVENT OCCURRED AS A RESULT OF DRUG INTERRUPTION DUE TO DEVICE RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779326 INOMAX DSIR (DELIVERY SYSTEM)/INOMAX DSIR CART (PN10018) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007 CT20090483

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR