BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1014087 · Received March 14, 2008

    Report

    Report Number
    6000002-2008-06224
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 29, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE YELLOW AND BLUE PORTS WERE REVERSED. IT WAS FURTHER REPORTED THAT THE YELLOW PORT COULD NOT BE FLUSHED. THE CATHETER WAS SWITCHED WITH A NEW CATHETER AND SAME ISSUE WAS IDENTIFIED. THE NURSES WERE ABLE TO IDENTIFY THE CORRECT PORTS, WHICH CORRECTED THE PROBLEM AND NO PT COMPLICATIONS WERE REPORTED. PACKAGE WERE THROWN AWAY AND LOT NUMBERS WERE UNABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other