BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICY CATHETER

    MDR report key: 1002316 · Received April 22, 2008

    Report

    Report Number
    2032474-2008-00001
    Event Type
    Death
    Date Received
    April 22, 2008
    Date of Event
    March 16, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ALSIUS CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MADE BASED ON RECEIPT OF CUSTOMER REPORT OF PT DEATH. WE ASKED FOR THE RETURN OF THE PRODUCT, HOWEVER, THE CUSTOMER INDICATED THAT THE CATHETER WAS DISPOSED POST AUTOPSY. EVAL BASED ON THE CUSTOMER REPORT: STANDARD CENTRAL LINE WAS PLACED IN THE PT'S RIGHT FEMORAL VEIN PRIOR TO THE USE OF ALSIUS ICY CATHETER. THE PHYSICIAN NOTED THAT THE PT WAS DIFFICULT TO ACCESS WHEN PLACING THE CENTRAL LINE. THERE ARE NO DIFFICULTIES NOTED IN THE MEDICAL RECORD WITH COOLING THE PT. DURING THE POST MORTEM, THE ALSIUS CATHETER FOUND TO BE IN THE CORRECT ANATOMICAL POSITION. FURTHER DISCUSSIONS WITH DR. KOCH INDICATED THAT THE INCIDENT IS UNDER INVESTIGATION BY THE HOSP RISK MGMT GROUP. SHE ALSO BELIEVES THAT THIS INCIDENT IS A RESULT OF AN OPERATOR ERROR.

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS RECEIVED FROM SHANDS HOSP: A FEMALE WAS ADMITTED TO THE HOSP FROM THE ER. THE PT HAD GONE TO THE UNIV OF FL CLINIC AND WAS SENT TO THE ER BECAUSE OF POOR OXYGEN SATURATION. WHILE IN THE ER, THE PT WENT INTO CARDIAC ARREST AND WAS SUBSEQUENTLY CODED AND BROUGHT BACK TO SPONTANEOUS CIRCULATION. DURING THE CODE, A STANDARD CENTRAL LINE WAS PLACED IN HER RIGHT FEMORAL VEIN. DR BORUCKI PLACED THE ORIGINAL LINE. IN HIS PROCEDURE NOTE, HE SAID THE PT WAS DIFFICULT TO ACCESS. THE PT THEN WAS MOVED TO THE MICU ON THE EVENING SHIFT. DR. WROTE THE ORDERS TO BEGIN COOLING THE PT WITH THE ICY CATHETER AND COOLGARD MACHINE. THERE WERE NO DIFFICULTIES NOTED IN THE MEDICAL RECORD ABOUT PROBLEMS COOLING THE PT. ON THE NEXT DAY, THE PT DIED FROM WHAT WAS IDENTIFIED POST MORTEM AS A RETROPERITONEAL BLEED FROM THE RIGHT FEMORAL VEIN. THE SITE OF THE BLEEDING WAS 15 CM ABOVE THE INSERTION SITE. THE SIZE OF THE HOLE WAS NOT NOTED, BUT DR. KOCH SAID IT WAS LARGE ENOUGH TO PASS THE INFLATED CATHETER THROUGH. THE CATHETER ITSELF WAS IN CORRECT ANATOMICAL POSITION. APPROXIMATELY 1.5 LITERS OF FLUID WERE FOUND IN THE PT'S ABDOMEN AND PELVIC AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY CATHETER HEAT EXCHANGE CATHETER DQO ALSIUS CORP. IC3893A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| O