BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERONEB SOLO, CONVENIENCE, 10/PK

    MDR report key: 2553218 · Received April 25, 2012

    Report

    Report Number
    3008604179-2012-00001
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    April 22, 2012
    Report Date
    April 23, 2012
    Manufacturer
    AEROGEN LTD
    Product Code
    CAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6), MD: "THIS IS A VERY SICK PT (B)(6) WITH NOW SEVERE RV DYSFUNCTION. HE WAS PLACED ON EPOPROSTENOL TWO DAYS AGO. HE WAS OVERALL TENUOUS, BUT RELATIVELY STABLE TODAY. AT SOME POINT, HE DEVELOPED SIGNIFICANT DESATURATION (SPO2 APPROX 80%), WHICH WAS NOT AMENABLE TO VENTILATOR CHANGES AND STANDARD THERAPY. THIS WAS VERIFIED BY BLOOD GASES, AND HIS PAO2 WAS AROUND 45 MMHG. HE SUBSEQUENTLY DEVELOPED VENTRICULAR ARRHYTHMIAS AND HYPOTENSION, FOR WHICH WE HAD TO INCREASE VASOACTIVE SUPPORT. WE PERFORM A GEE, A CHEST X-RAY, AND AN EMERGENT BRONCHOSCOPY, ALL WITHOUT ANY FINDINGS THAT WE DIDN'T ALREADY KNOW ABOUT. I WAS ABOUT TO TAKE THIS PT TO THE CT SCANNER FOR A CONTRAST CT OF THE CHEST TO RULE OUT A PULMONARY EMBOLISM, WHEN THE TWO RESPIRATORY THERAPISTS FIGURED OUT THAT THE EPOPROSTENOL CHAMBER WAS DRIPPING AND THE DELIVERY CHANNEL WAS OBVIOUSLY CLOGGED OFF...THE PT MUST HAVE HAD NO EPOPROSTENOL FOR WHILE AND PROBABLY DEVELOPED SUCH BAD REBOUND PULMONARY HYPERTENSION THAT HIS RV JUST COULD NOT HANDLE IT. IT WAS IMPRESSIVE HOW QUICKLY CONDITIONS CHANGED AFTER HE WAS PUT BACK ON WITH A NEW DRUG CHAMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AERONEB SOLO, CONVENIENCE, 10/PK CAF AEROGEN LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EPOPROSTENOL