BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 6051933 · Received October 24, 2016

    Report

    Report Number
    3004531588-2016-00070
    Event Type
    Death
    Date Received
    October 24, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 7, 2016
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR (B)(4) WAS CREATED AS COMPLAINT (B)(4). THE DEVICE INVESTIGATION WAS COMPLETED ON 24-OCT-2016. THE (B)(4) RSC WAS NOT ABLE TO REPRODUCE THE DELIVERY FAILURE ALARM DUE TO APPARENT IPL FAILURE BUT WAS ABLE TO CONFIRM IT IN THE SERVICE LOG AT THE TIME OF THE REPORTED COMPLAINT. THIS DELIVERY FAILURE WAS CONFIRMED TO CAUSE A SYSTEM SHUT DOWN WHICH WITHDREW DRUG FROM THE PATIENT. THE 50018 MAIN BOARD WAS REPLACED AS PRECAUTION DUE TO THE SERVICE LOG FINDINGS. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. THE ROOT CAUSE FOR THIS REPORT WAS DELIVERY FAILURE; APPARENT IPL FAILURE DUE TO MAIN BOARD FAILURE. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER THE COMPANY'S QUALITY SYSTEM.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A RESPIRATORY THERAPIST (RT) FROM THE (B)(6) CALLED MALLINCKRODT CUSTOMER CARE TO REPORT A DELIVERY FAILURE ALARM AND PATIENT DEATH WITH INOMAX DSIR (B)(4). THE PATIENT WAS A (B)(6) MALE INFANT BORN ON (B)(6) 2016 ACDT AND WAS A (B)(6) GRAMS. INOMAX WAS INITIATED ON (B)(6) 2016 AT 20:40 ACDT AT 20PPM DUE TO MECONIUM ASPIRATION SYNDROME AND PERSISTENT PULMONARY HYPERTENSION OF THE (B)(6) VIA INOMAX DSIR PLUS SERIAL NUMBER (B)(4). THE PATIENT ALSO HAD A DIAGNOSIS OF HYPOXIC ISCHEMIA. THE PATIENT WAS RECEIVING THE FOLLOWING MEDICATIONS: FENTANYL, ADRENALINE, DOPAMINE, HYDROCORTISONE, AND PENICILLIN. NO DOSES WERE SUPPLIED. THE PATIENT WAS MECHANICALLY VENTILATED VIA LIFE SUPPORT SLE 5000 VENTILATOR IN THE OSCILLATORY MODE. ON (B)(6) 2016 AT 06:00 ACDT WHILE IN THE ROOM WITH THE PATIENT, THE NURSE WITNESSED A DELIVERY FAILURE ALARM. THE PATIENT'S OXYGEN SATURATION DECREASED TO THE MID 60'S. THE PATIENT WAS MANUALLY VENTILATED WITH A NEOPUFF MANUAL RESUSCITATOR WITH THE INOBLENDER AT 20PPM INOMAX AND 100% OXYGEN. THE PATIENT WAS PLACED ONTO ANOTHER DSIR + AT 20PPM. THE PATIENT'S OXYGEN SATURATION REMAINED IN THE MID 60'S TO 70% AS OF 90 MINUTES LATER. THE NURSE CALLED IN TO THE COMPANY APPROXIMATELY 90 MINUTES AFTER THE PATIENT EVENT. THE PATIENT WAS DISCONTINUED FROM INOMAX AT 20PPM ON (B)(6) 2016 AT 20:20 ACDT AND EXPIRED ON (B)(6) 2016 AT 20:40ACDT. THE CAUSE OF DEATH IS REPORTED AS HYPOXIC ISCHEMIA. IN THE REPORTERS MEDICAL OPINION THE ADVERSE EVENT WAS RESOLVING AND IS NOT RELATED TO THE PATIENT DEATH. INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO THE COMPANY FOR SERVICE EVALUATION. THIS IS BEING REPORTED AS IT IS CONSIDERED A REPORTABLE MALFUNCTION BASED ON THE COMPLETED INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701401 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10023

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA