BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 1150163 · Received September 4, 2008

    Report

    Report Number
    2087532-2008-00090
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FACILITY CHIEF MEDICAL DIR REPORTED THAT A CHRONIC HEMODIALYSIS PT SUFFERED A SEVERE REACTION AT THE BEGINNING OF A ROUTINE DIALYSIS TREATMENT ON A PHOENIX MACHINE. APPROX 16 MINUTES INTO HIS HEMODIALYSIS TREATMENT, THE PT PRESENTED WITH SEVERE RESPIRATORY DISTRESS REQUIRING IV EPINEPHRINE, METHYLPREDNISOLONE, BENADRYL AND ADMINISTRAITON OF OXYGEN. THE PT'S BLOOD WAS NOT RETURNED RESULTING IN A 218 ML BLOOD LOSS. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT OBSERVATION, DISCHARGED THE NEXT DAY AND IS NOW DIALYZING IN THE CHRONIC DIALYSIS UNIT. THIS PARTICULAR MACHINE WAS USED DURING THE FIRST SHIFT ON THE DAY OF THIS INCIDENT WITHOUT REPORTED PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT FII GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R