BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 3093837 · Received April 27, 2013

    Report

    Report Number
    3003793491-2013-00489
    Event Type
    Death
    Date Received
    April 27, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FLUID WAS COMING OUT OF THE PROXIMAL PORT. BALLOONS WERE INTACT. ADDITIONAL INFORMATION WAS RECEIVED WHEREBY IT WAS INDICATED THAT (B)(6) FEMALE PATIENT WAS HOSPITALIZED FOR ORIF IN LEFT ANKLE. A QUATTRO CATHETER WAS INSERTED INTO THE FEMORAL VEIN. INSERTION WAS SMOOTH, NO PROBLEMS WERE NOTED WHILE SLIDING THE CATHETER OVER THE WIRE. THERAPEUTIC HYPOTHERMIA S/P PEA ARREST WAS PERFORMED. THE CATHETER WAS IN THE PATIENT FOR 62 HOURS. NO ADJUNCT TEMPERATURE MANAGEMENT THERAPY WAS BEING USED. PATIENT TEMPERATURE AT THE TIME OF THE IVTM THERAPY WAS 38.1 DEGREE CELSIUS. TARGET TEMPERATURE AT THE TIME OF THE ISSUE WITH CATHETER WAS 32.0 DEGREE CELSIUS. IT WAS OBSERVED 2 HOURS PRIOR TO RE-WARM (24 HOURS INTO THERAPEUTIC HYPOTHERMIA) THAT THE 500CC BAG WAS LOW IN VOLUME WITH NO NOTICEABLE LEAK IN THE BED OR ON THE FLOOR. PATIENT WAS RE-WARMED AT 0.2 DEGREE CELSIUS/HR FROM 32.0 DEGREE CELSIUS - 36.5 DEGREE CELSIUS. SYSTEM HAD BEEN RUNNING 24 HOURS IN COOLING MAX POWER MODE. ALARM SYSTEMS WERE NOT NOTICED. PATIENT WAS MAINTAINING TEMPERATURE WITH NO ISSUES. PHYSICIAN MADE AWARE, BUT DECIDED NOT TO REPLACE CATHETER. A NEW 500CC BAG WAS HUNG EVERY 2-3 HOURS DURING RE-WARMING RESULTING IN APPROXIMATELY 6 LITERS OF FLUID GIVEN TO PT. PHYSICIAN WAS AWARE AND OK WITH EXTRA FLUID DUE TO HYPOTENSION. RE-WARMING OF THE PATIENT WAS SLIGHTLY PROLONGED, BUT ABLE TO RETURN PATIENT TO 36.4 DEGREE CELSIUS WHEN THERAPY STOPPED. ONCE THE CATHETER WAS AGAIN HOOKED UP TO THE IVTM SYSTEM AND ALL BALLOON'S WERE INTACT, FLUID WAS OBSERVED TO BE LEAKING OUT OF THE PROXIMAL INFUSION PORT. PATIENT EXPIRED. SUPPORT WAS WITHDRAWN DUE TO ANOXIC BRAIN INJURY. CUSTOMER INDICATED THAT DEATH WAS NOT ATTRIBUTED TO THE CATHETER, AND IT IS BELIEVED THAT PATIENT DIED ON (B)(6) 2013, THE DAY THE CATHETER WAS REMOVED. AFTER DISCUSSION WITH THE FAMILY ABOUT THE ANOXIC BRAIN INJURY, IT WAS DECIDED TO WITHDRAW SUPPORT AND PROVIDE COMFORT CARE ONLY. IT IS BELIEVED THAT THE CAUSE OF DEATH WAS LISTED AS ANOXIC BRAIN INJURY S/P PEA ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183255 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC. IC-4593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR