BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 525567 · Received May 19, 2004

    Report

    Report Number
    525567
    Event Type
    Other
    Date Received
    May 19, 2004
    Date of Event
    March 1, 2004
    Report Date
    April 1, 2004
    Manufacturer
    GAMBRO RENAL PRODUCTS
    Product Code
    KOC
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT NEARING END OF DIALYSIS AND PRACTIONER IN ROOM HEARD SWOOSHING NOISE FROM MACHINE. SHE WENT TO EXAMINE BUT THE SOUND STOPPED, CHAMBER LOOKED GOOD. NEXT AIR, ALARM WENT OFF AND MACHINE AUTOMATICALLY SHUT OFF. VENOUS CHAMBER 1/2 FULL OF FOAM AND SOME FOAM NOTED IN ARTERIAL CHAMBER. NO OBVIOUS AIR SEEN. IT WAS DISCOVERED LATER THAT PATIENT HAD AIR IN MULTIPLE BLOOD VESSELS AND IN RIGHT ATRIUM. HOWEVER, IT IS NOT CLEAR IF IT WAS RELATED TO THIS EVENT. PATIENT DID NOT SUFFER SEQUALE FROM THIS. STAFF HAS CONTACTED GAMBRO SERVICE WHO IS COMING OUT TO INSPECT DEVICE. STAFF ARE NOT USING DEVICE UNTIL MACHINE IS CLEARED BY GAMBRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS DELIVERY SYSTEM KOC GAMBRO RENAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other