BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERONEB PROFESSIONAL NEBULISER SYSTEM

    MDR report key: 2577645 · Received April 27, 2012

    Report

    Report Number
    3003399703-2012-00001
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    April 22, 2012
    Report Date
    July 27, 2012
    Manufacturer
    AEROGEN LTD
    Product Code
    CAF
    PMA / PMN Number
    K0706462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING DEVICE RETURN TO COMPLETE THE DEVICE EVALUATION AND IDENTIFY DEVICE LOT NUMBER AND MANUFACTURING DATE.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6), 'THIS IS A VERY SICK PATIENT S/P AVR 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 ~ 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 PERFORMED A TEE, 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 PATIENT 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 PATIENT 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 PROFESSIONAL NEBULISER SYSTEM AERONEB SOLO CONVENIENCE 10/PK CAF AEROGEN LTD AG-AS3350-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EPOPROSTENOL