BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1080074 · Received July 15, 2008

    Report

    Report Number
    3004531588-2008-00002
    Event Type
    Other
    Date Received
    July 15, 2008
    Date of Event
    May 30, 2008
    Report Date
    July 14, 2008
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USE ERROR REPORTED BY USER FOLLOWING THEIR INVESTIGATION AND (B) (6) FOLLOW UP. THEREFORE THE INOMAX DS WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B) (6) 2008, AN ADVERSE EVENT WAS REPORTED VIA A HEALTH CARE PROFESSIONAL. THE ADVERSE EVENT OCCURRED WHEN A HEALTH CARE PROFESSIONAL ENGAGED THE INOMAX DS BACK UP SWITCH WHILE 20 PARTS PER MILLION (PPM) OF INHALED NITRIC OXIDE (INO) WAS STILL BEING DELIVERED TO THE PT VIA INOMAX DS (B) (4). THE INO EXCEEDED 100 PPM AND AS DESIGNED, ALARMED AND CEASED DRUG DELIVERY. THE BACKUP SWITCH WAS TURNED ON IN A MISTAKEN ATTEMPT TO TURN ON FLOW FOR MANUAL BAGGING AND THE ALARMS THAT IMMEDIATELY OCCURRED WERE IGNORED OR MISUNDERSTOOD. AT THE TIME, THERE WAS A LARGE SIGN ATTACHED TO THE FRONT OF THE INOMAX DS DEVICE EXPLAINING HOW TO TURN ON THE GAS FLOW FOR MANUAL VENTILATION. BUT IT WAS NOT OPTIMALLY POSITIONED AND WAS OVERLOOKED. THE REPORTER INDICATED THAT EARLIER THE SAME DAY, THE HEALTH CARE PROFESSIONAL INVOLVED IN THE INCIDENT WAS ASKED BY THE RESPIRATORY THERAPIST IF THEY KNEW HOW TO TURN ON THE FLOW FOR MANUAL VENTILATION. THE HEALTH CARE PROFESSIONAL INDICATED AN UNDERSTANDING OF THE PROCEDURE. DURING THE EVENT, A THERAPIST WAS PAGED AND THE SITUATION WAS CORRECTED. IT WAS REPORTED THE EVENT OCCURRED DUE TO HUMAN ERROR, INCOMPLETE EDUCATION, AND INADEQUATE POSITIONING OF THE SIGNAGE BY THE FACILITY. FOLLOWING THIS EVENT, ADDITIONAL EDUCATIONAL SESSIONS WERE CONDUCTED, THE SIGNAGE POSITIONING WAS MODIFIED BY THE FACILITY, AND THE BACKUP SWITCH WAS INACTIVATED BY USING A THIN RIBBON OF REINFORCED STRAPPING TAPE. THE REPORTER DID NOT THINK THE EVENT WAS SERIOUS. FOLLOW UP INFO WAS RECEIVED ON JUNE 27, 2008, VIA A MEDWATCH REPORT RECEIVED FROM THE FDA THAT WAS SUBMITTED BY THE HOSPITAL. THE PT IS A (B) (6), (B) (6) FEMALE WITH A WEIGHT OF (B) (6). SHE WAS BORN PREMATURE AND HAS A HISTORY OF CHRONIC LUNG DISEASE AND PULMONARY HYPERTENSION. ON (B) (6) 2008, THE PT HAD A SUDDEN DESATURATION (VALVES NOT REPORTED) DUE TO THE ENDOTRACHEAL TUBE BEING UNPLUGGED. WHEN THE NURSE ATTEMPTED TO USE THE BAG VALVE MASK (BVM) FROM THE SYSTEM, IT WOULD NOT INFLATE. THE RESPIRATORY THERAPIST WAS CALLED IMMEDIATELY. THE NURSE TURNED ON THE INOMAX DS BACKUP SWITCH IN AN ATTEMPT TO TROUBLESHOOT THE PROBLEM; APPLIED 100% OXYGEN BAG VALVE MASK (BVM), AND THEN CORRECTED THE SYSTEM. THE NITRIC OXIDE DELIVERY SYSTEM'S SWITCH DISPLAYED A SIGN SAYING, "DO NOT TURN ON". ADDITIONAL INFO ATTACHED TO THE SYSTEM DESCRIBED HOW TO TURN ON THE GAS FLOW MANUALLY, AS DID EDUCATION POSTERS DISPLACED IN THE INTENSIVE CARE UNIT (ICU). THE RESPIRATORY THERAPIST SAID THEY WERE GOING TO CHECK WITH THE NURSE INVOLVED TO SEE IF SHE KNEW HOW TO VENTILATE THE PT MANUALLY. THE NURSE REPLIED YES, BUT SHE OBVIOUSLY DID NOT FULLY UNDERSTAND THE PROCEDURE IN THIS PARTICULAR CASE. THIS WAS AN EXAMPLE OF AN OPERATOR ISSUE ERROR AND NOT A MACHINE ISSUE.

    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 8 MO