BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD

    MDR report key: 3140939 · Received June 3, 2013

    Report

    Report Number
    2015691-2013-20225
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED WITH AN UNATTACHED INTRODUCER (UNKNOWN MANUFACTURER). THE DISTAL END OF THE CONTAMINATION SHIELD WAS ATTACHED ON THE CATHETER BODY APPROXIMATELY 39CM AND AT THE PROXIMAL END. EXAMINATION OF THE CATHETER BODY AND THE DISTAL TIP WAS PERFORMED AND INDENTATIONS WERE OBSERVED 39CM PROXIMAL OF THE CATHETER TIP. THE TIP OF THE CATHETER WAS ALSO FOUND TO HAVE A CLEAR HARD SUBSTANCE OVER THE TIP SURFACE. ALL THRU-LUMENS WERE PATENT AND DID NOT LEAK. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND DID NOT LEAK. THE CLEAR SUBSTANCE ON THE TIP OF THE CATHETER WAS REMOVED AND SENT TO CHEMISTRY FOR TESTING, WHICH INDICATED THAT THE SUBSTANCE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO SULFONATED FATTY ACID LIKE MATERIAL. THE RETURNED INTRODUCER WAS POSITIONED NEXT TO THE INDENTATIONS IN THE CATHETER BODY AND IT WAS NOTED THAT THE INTRODUCER SHEATH EXTENDED OVER BOTH PROXIMAL PORTS. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. REVIEW OF THE AVAILABLE INFORMATION INDICATES THE CRYSTALLIZATION REPORTED MAY HAVE RESULTED FROM MIXING OF MEDICATIONS. THE BACKING UP OF FLUIDS FROM THE PROXIMAL INFUSION PORT APPEARS TO BE RELATED TO THE LENGTH OF THE INTRODUCER USED WITH THE CATHETER. THE CAUSE OF THE HARDENED SUBSTANCE ON THE DISTAL END OF THE CATHETER IS CURRENTLY UNKNOWN AND AN INVESTIGATION WAS OPENED TO DETERMINE THE CAUSE AND IMPLEMENT ANY NECESSARY ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CRYSTALS WERE NOTED IN THE INTRODUCER AND THE INFUSION PUMPS WERE ALARMING THAT THERE WAS AN OCCLUSION. THE CLINICIAN SEPARATED ALL THE MEDICATIONS. AT A LATER TIME, LEAKAGE WAS NOTED IN THE CVP PORT AND BACK UP OF IV MEDICATION WAS NOTED IN THE TUBING FROM THE PROXIMAL PORT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244093 SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 831HF75

    Patients

    Seq Age Sex Outcome Treatment
    1