BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2132163 · Received June 17, 2011

    Report

    Report Number
    2015691-2011-15730
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS NOT SAVED AND COULD NOT BE RETURNED FOR EVALUATION; HOWEVER, ONE CATHETER WAS RECEIVED AND EVALUATED WITH THE SAME REPORTED EVENT. THERE WAS NO DEFECT FOUND. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. NO ACTIONS WILL BE TAKEN AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CARDIAC OUTPUT NUMBERS THAT WERE OBSERVED WERE "ALL OVER THE PLACE" EITHER HIGH OR LOW AND NOT CORRESPONDING WITH THE PATIENT'S CLINICAL STATUS. WHEN THESE NUMBERS ARE NOTED THEY RECALIBRATE, RECALCULATE THE NUMBERS ON THE MONITOR AND CHANGE THE MONITOR AND THE THERMISTOR CABLE. THESE NUMBERS ARE OBSERVED IN THE ICU AND THE CCO NUMBERS THAT ARE OBSERVED RANGE FROM 3.6 AND THEN THE MEASUREMENT OF 1.1 IS OBSERVED. THE PATIENT WAS TRANSFERRED AFTER HAVING OPEN HEART PROCEDURES FROM OR TO ICU, EVENTS OCCURRED IN ICU. CUSTOMER INDICATED THAT THEY ARE USING THE VIG 1 MONITOR. THERE WAS NO ERROR MESSAGES OBSERVED. IT IS NOTED THAT THE PATIENT'S STATUS IS FINE, THE PATIENT'S VITAL SIGNS ARE CHECKED, RE-CALIBRATE CATHETER, MIXED VENOUS GAS IS TAKEN TO CONFIRM STATUS OF PATIENT AND THE PATIENT IS FINE. THE CATHETERS ARE PLACED NO LONGER THAN 4-6 HOURS USUALLY COME OUT BY 12 HOURS. THE CUSTOMER SPOKE WITH OUR TECHNICAL SERVICE GROUP TO TROUBLESHOOT - SHOOT A BOLUS BY PUTTING IN THE CORRECT COMPUTATION CONSTANT (INPUT INTO THE MONITOR OF THE MODEL NUMBER OF THE CATHETER) AND THEN ANOTHER BOLUS WITH THE SPACELAB (BEDSIDE MONITOR) COMPARE TO THE VIGILANCE MONITOR. THERE HAVE BEEN NO PATIENT COMPLICATIONS. THERE WAS NO CABLE OR MONITOR BEING REPORTED, CUSTOMER FELT THAT THIS IS A CATHETER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINOUS CARDIAC OUPTUT CATHETER DYG EDWARDS LIFESCIENCES, PR CCOCATHUNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1