BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 547980 · Received September 9, 2004

    Report

    Report Number
    MW4003771
    Event Type
    Injury
    Date Received
    September 9, 2004
    Date of Event
    August 11, 2004
    Report Date
    August 17, 2004
    Manufacturer
    GAMBRO INC.
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING HEMODIALYSIS IN THE RENAL UNIT. RN NOTED FOAM IN VENOUS BLOOD LINE. AIR DETECTOR DID NOT ALARM VENOUS LINE CLAMPED. AIR REMOVED FROM LINE AND RECONNECTED TO PT. PT C/O S0B, INCREASED RESP RATE. O2 APPLIED, STAT CXR-NORMAL. SYMPTOMS RESOLVED IN 15 MINS, DIALYSIS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS MACHINE FII GAMBRO INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention