BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2855170 · Received December 3, 2012

    Report

    Report Number
    2015691-2012-18744
    Event Type
    Death
    Date Received
    December 3, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 6, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SWAN-GANZ CATHETER WAS RECEIVED WITH AN ATTACHED CONTAMINATION SHIELD AND AN ATTACHED NON VENTED CAP TO PROXIMAL HUB. THE PROXIMAL END OF THE CONTAMINATION SHIELD WAS ATTACHED AT THE 98CAM AREA AND UPON REMOVAL OF THE CONTAMINATION SHIELD, A KINK WAS NOTED AT THE 98CM AREA. DRIED BLOOD WAS FOUND INSIDE THE OPTICAL CONNECTOR. THERE WAS NO VISIBLE DAMAGE NOTED ON THE CATHETER BODY. DRIED BLOOD WAS ALSO FOUND IN THE P.A. DISTAL, PROXIMAL INJECTATE, AND PROXIMAL INFUSION LUMENS. LEAKAGE AND PATENCY FOR ALL THROUGH LUMENS COULD NOT BE CONFIRMED DUE TO DIFFICULTY REMOVING DRIED BLOOD IN THE LUMENS, AND THEREFORE LOCATION OF LEAKAGE COULD NOT BE CONFIRMED. THE COMPLAINT OF LEAKAGE FROM THE BLUE SVO2 SENSOR MODULE WAS CONFIRMED; HOWEVER, THE SOURCE OF LEAKAGE COULD NOT BE CONFIRMED DUE TO DRIED BLOOD INSIDE THE LUMENS. AN INVESTIGATION WAS OPENED TO DETERMINE THE CAUSE OF THE COMPLAINT AND IMPLEMENT ANY NECESSARY ACTIONS.

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, AT LAST CONTACT, THE HOSPITAL HAD NOT AGREED TO RELEASE IT. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE PRODUCT, NOR COULD IT BE DETERMINED IF DAMAGES OR DEFECTS EXISTED ON THE UNIT. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE CATHETER IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF DEATH WAS DUE TO MULTI-ORGAN FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID INFUSING THROUGH THE VIP PORT WAS LEAKING OUT OF THE BLUE SVO2 SENSOR MODULE. THROUGH FOLLOW-UP INVESTIGATION, IT WAS DETERMINED THAT IT WAS VASPRESSOR MEDICATIONS LEAKING, WHICH "RESULTED IN THE PATIENT BEING UNDER MEDICATED." WHEN THE MEDICATION WAS MOVED TO ANOTHER IV SITE, THERE WAS MARKED IMPROVEMENT IN HIS VITAL SIGN SIGNS AND THE VASOPRESSOR INFUSION WAS DECREASED BY HALF. THE CATHETER WAS REPLACED. THE REPORTER COMMENTED: "IN THIS POST OP PATIENT WHO WENT INTO RENAL FAILURE, WITH THE NEED FOR DIALYSIS WAS HYPO-PERFUSION A POTENTIAL SOURCE?" AS REPORTED, THE PATIENT DID NOT RECOVER KIDNEY FUNCTION AND EVENTUALLY EXPIRED. THE ACTUAL CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 746HF8

    Patients

    Seq Age Sex Outcome Treatment
    1 Death