BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1021563 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06333
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 24, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT A VIGILANCE ERROR MESSAGE "CHECK CATHETER AND CABLE CONNECTION" WAS OBSERVED. A CUT DOWN OF THE CATHETER NEAR THE LEAD WIRE TO THERMAL FILAMENT TRACE WELD REVEALED THAT BOTH LEAD WIRES WERE FOUND TO BE DETACHED AT THE WELD. BLOOD RESIDUE WAS VISIBLE INSIDE THE THERMISTOR CONNECTOR. A SLIT WAS FOUND, 0.03 INCHES IN LENGTH, AT THE 33.5 CM AREA, WHICH ENTERED THE THERMISTOR LUMEN. CATHETER BODY APPEARED TO HAVE BEEN STRETCHED WITH VISIBLE RIPPLES IN THE THERMISTOR LEADWIRE INSIDE THE CATHETER BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SIX HOURS AFTER THE INSERTION, CEDV ALARM WENT OFF AND IT BECAME UNABLE TO MEASURE CONTINUOUS CARDIAC OUTPUT. CUSTOMER TRIED TO CHANGE 70CC2 CABLE AND FOUND BLOOD LEAKAGE FROM THE THERMISTOR CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 774HF75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other