BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 17187126 · Received June 22, 2023

    Report

    Report Number
    3010617000-2023-00518
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 13, 2023
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED PROBLEM OF "CONSPICUOUS AIR OBSERVED AT THE CATHETER TIP" WAS NOT CONFIRMED DURING THE VISUAL INSPECTION OR FUNCTIONAL TESTING OF THE RETURNED CATHETER. NO ISSUES OR DISCREPANCIES WERE FOUND. NO DEVICE MALFUNCTION WAS OBSERVED DURING THE TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE CATHETER OR ON THE CATHETER TIP. BLOOD RESIDUES WERE ALSO OBSERVED ON THE BALLOONS AND IN LUERED TUBINGS. A FUNCTIONAL PRESSURE LEAK TEST WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, NO ISSUES WERE OBSERVED. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. IN ADDITION, THE RETURNED CATHETER WAS CONNECTED TO THE RETURNED (START-UP KIT) SUK AND RAN ON A PERISTALTIC PUMP FOR 10 MINUTES AT A HIGH-SPEED RATE. NO LEAK OR DAMAGE WAS FOUND. NO AIR BUBBLE WAS OBSERVED ON THE CATHETER TIP. NO STRANGE NOISES WERE OBSERVED DURING TESTING. THE CATHETER FUNCTIONED AS INTENDED. DURING FURTHER FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO THE RETURNED SUK AND RAN ON THE THERMOGARD CONSOLE SYSTEM, RUNNING IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE AT 37°C FOR 60 MINUTES AND RUNNING IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE AT 35°C FOR 60 MINUTES. THE BALLOONS WERE PROPERLY WARMING DURING THE WARMING MODE AND COOLING DURING THE COOLING MODE. THE SUK RED PINWHEEL AND THE PUMP ROLLER WAS ROTATING AS NORMAL. NO AIR BUBBLE WAS OBSERVED ON THE CATHETER TIP. NO STRANGE NOISES WERE OBSERVED DURING TESTING AND THE CATHETER FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 0

    EVENT OF AIR EMBOLISM WAS ASSESSED AS NOT SERIOUS. BASED ON AVAILABLE INFORMATION, EVENT WAS NOT RELATED TO THE ZOLL CATHETER. AIR POCKETS WERE OBSERVED AT THE CATHETER TIP, THEN AIR WAS DETECTED IN THE KIDNEY AND LIVER DUE TO AIR EMBOLISM. THE DEVICE WAS REPLACED AND THE NEW ICY CATHETER PERFORMED AS INTENDED WITHOUT PROBLEMS. THERE WAS NO DATA FOR INJURY OF THE KIDNEY AND LIVER. HYPOTHERMIA WAS SUCCESSFULLY ACHIEVED. BASED ON TESTING AND INSPECTION, THE DEVICE HAD NO LEAKS AND OPERATED TO SPECIFICATION WHEN TESTED. NO AIR CAN BE INTRODUCED IF THE SYSTEM HAS BEEN SET UP CORRECTLY. THE DESCRIPTION OF THE BUBBLE IN THE CENTER LUMEN, STATIONARY AT THE DISTAL TIP COULD ONLY HAVE BEEN INTRODUCED DURING INTRODUCTION OR INFUSION. THE COOLANT LOOP IS UNDER PRESSURE. HAD IT FAILED, SALINE WOULD HAVE BEEN INTRODUCED TO THE PATIENT, BUT THE CUSTOMER REPORTS THAT THE AIR TRAP WAS FULL. THE AIR POCKETS WERE LIKELY DUE TO INCORRECT SETUP OR INTRODUCTION DURING INFUSION OR FLUSHING OF THE DISTAL LUMEN. AIR EMBOLISM IS AN UNANTICIPATED EVENT. THE REPORTED EVENT IS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    A FEMALE PATIENT IN CARDIAC ARREST WAS RESUSCITATED. POST-RESUSCITATION, IVTM THERAPY WAS INITIATED. THE ICY CATHETER (LOT 181534) WAS INSERTED SMOOTHLY ON THE FIRST ATTEMPT INTO THE LEFT FEMORAL VEIN WITHOUT ISSUES. NO ISSUES WERE REPORTED DURING THE PRIMING OF THE SYSTEM. AFTER 2 HOURS, CONSPICUOUS AIR WAS OBSERVED BY SONOGRAM AT THE CATHETER TIP. WHEN THE ROLLER PUMP WHEEL ROTATES, THE AIR IS VISIBLE. WHEN IT STANDS STILL, THE AIR IS NOT. IMMEDIATELY, USER ERROR WAS RULED OUT. A LEAK CHECK WAS PERFORMED PER THE CATHETER IFU. THE CONNECTIONS AND PERFUSORS (FOR MEDICATION) WERE CHECKED. NO ABNORMALITIES WERE OBSERVED. THE START-UP KIT (SUK) WAS CHECKED. THE AIR TRAP WAS COMPLETELY FILLED, AND NO AIR WAS OBSERVED IN THE SUK. NO FLUID LOSS WAS NOTICED IN THE SALINE BAG AND NO AIR TRAP ALARM WAS DISPLAYED ON THE THERMOGARD XP IVTM SYSTEM. HIGH FLOW RATES WERE OBSERVED ON THE 3 INFUSION LUMENS: NOADRENALINE AT 40ML/H + DOBUTAMINE WITH UNCLEAR FLOW RATE (USUALLY 2-4 ML/H). VOLUME AT 250 TO 500 ML/H AND ONE LEG WAS FILLED WITH NACL 2ML/H. NO ABNORMALITIES, MISCONNECTIONS, FLUID LOSS, OR AIR POCKETS IN PERFUSOR SYRINGE THAT WAS USED TO ADMINISTER MEDICATION WERE OBSERVED. AS A RESULT OF THE OBSERVED AIR, THE PATIENT SUFFERED AIR EMBOLISMS IN THE KIDNEY AND LIVER THAT CAN STILL BE VISUALIZED. NO INTERVENTION IS CURRENTLY NEEDED FOR THE AIR EMBOLI. THE PATIENT'S RESPIRATORY STATUS IS STABLE, AND NO PULMONARY EMBOLISM IS DETECTABLE. THE PATIENT'S CONDITION IS VERY CRITICAL AND UNSTABLE BUT THE CUSTOMER REPORTS THAT IT IS UNCLEAR IF HER CONDITION IS DUE TO THE EMBOLI, OR DUE TO HER AGE, MANY PREVIOUS ILLNESSES, AND/OR THE RECENT RESUSCITATION EVENT. AFTERWARDS, A NEW ICY CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN AND IVTM THERAPY WAS CONTINUED USING THE SAME SUK AND CONSOLE. NO AIR COULD BE VISUALIZED AT THE CATHETER TIP, AND THERAPY IS RUNNING SMOOTHLY. THE PATIENT IS STILL IN HYPOTHERMIA. THE DIAGNOSIS OF AIR EMBOLISM WAS MADE PURELY BY CHANCE: EACH PATIENT AT THE BEGINNING OF AN ICU STAY RECEIVES FAST TRACK A SONO (A SONOGRAM OF ALL ORGANS), AS PART OF THE ANAMNESIS. THE AIM WAS TO EXCLUDE A URINARY STASIS, WHICH INITIALLY LED TO THE DISCOVERY OF AIR POCKETS IN THE KIDNEY. WHEN THE CAUSE WAS INVESTIGATED, THE CATHETER WAS SONICATED AND THE PROBLEM OF AIR AT THE CATHETER TIP WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029242 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC IC-3893AE 181534 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other