BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU

    MDR report key: 23674534 · Received November 28, 2025

    Report

    Report Number
    3010617000-2025-00815
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    November 7, 2025
    Report Date
    January 2, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K081936
    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

    D4. (SUSPECT MEDICAL DEVICE, EXPIRATION DATE) WAS UPDATED. H4. (DEVICE MANUFACTURE DATE) WAS UPDATED. THE REPORTED COMPLAINT OF OBSERVING A PARTIALLY DEPLETED SALINE BAG WAS NOT CONFIRMED DURING VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SOLEX 7 CATHETER. NO ISSUES OR DISCREPANCIES WERE FOUND. NO LEAKS, DAMAGE, OR DEVICE MALFUNCTIONS WERE OBSERVED DURING TESTING. THE CATHETER FUNCTIONED AS INTENDED. DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER, ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. NO LEAKS OR ISSUES WERE FOUND ON THE CATHETER. THE BALLOON DID NOT LEAK DURING TESTING. IN ADDITION, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD START-UP KIT (SUK) AND RUN ON A PERISTALTIC PUMP FOR 10 MINUTES AT A HIGH SPEED. NO LEAKS WERE OBSERVED, AND THE CATHETER FUNCTIONED AS INTENDED. DURING FURTHER FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD SUK AND RAN ON A THERMOGARD CONSOLE SYSTEM, RUNNING IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE OF 37°C FOR 60 MINUTES AND RUNNING IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE OF 35°C FOR 60 MINUTES. NO LEAK WAS OBSERVED ON THE CATHETER. THE BALLOON WAS PROPERLY WARMING DURING THE WARMING MODE AND COOLING DURING THE COOLING MODE. THE RED PINWHEEL OF THE SUK WAS SPINNING AS NORMAL. NO PROBLEM WAS FOUND, AND THE CATHETER FUNCTIONED AS INTENDED. RE-TRAINING OF THE CUSTOMER ON USAGE OF THE CATHETER TO ENSURE APPROPRIATE LOCATION OF THE CATHETER DURING COOLING THERAPY COULD BE BENEFICIAL.

    Additional Manufacturer Narrative · 0

    THE CATHETER HAS BEEN RECEIVED BY ZOLL AND IS PENDING FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. IT SEEMS THAT AROUND 50 ML OF STERILE COLD SALINE WAS ENTERED INTO THE PATIENT'S VASCULATURE. SWELLING AT THE INSERTION SITE WAS REPORTED. THE EVENT WAS ASSESSED AS NOT SERIOUS BECAUSE IT DID NOT MEET THE CRITERIA FOR SERIOUSNESS. BASED ON AVAILABLE INFORMATION, THE EVENT WAS RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION. SWELLING SUBCUTANEOUS TISSUE AROUND THE ZOLL CATHETER IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH THE USE OF ANY CATHETER. THE REPORTED EVENT IS CASUALLY RELATED TO THE ZOLL CATHETER AND PROCEDURE.

    Description of Event or Problem · 0

    A POST-CARDIAC ARREST PATIENT RECEIVED IVTM THERAPY WITH THE SOLEX 7 CATHETER (LOT # 206518). THE CATHETER WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN IN A SINGLE INSERTION ATTEMPT BY THE SENIOR ATTENDING PHYSICIAN. NO OTHER LINE WAS PLACED IN THE SAME VEIN. AFTER PLACEMENT, AN X-RAY CONFIRMED THE CATHETER'S CORRECT POSITION. MEDICATIONS ADMINISTERED THROUGH THE INFUSION LUMEN INCLUDED SUFENTANIL, MIDAZOLAM, NORMOFUNDIN, HEPARIN, NORADRENALINE, AND JONOSTERIL. FOLLOWING INDUCTION OF THERAPEUTIC HYPOTHERMIA TO 34.5 °C, THE PATIENT WAS GRADUALLY REWARMED AT A RATE OF 0.25 °C PER HOUR UNTIL REACHING 36.5 °C. ONCE THE TARGET TEMPERATURE WAS REACHED, THE SYSTEM WAS SET TO MAINTAIN IT. THE THERMOGARD CONSOLE DID NOT TRIGGER ANY ALARMS DURING THERAPY. WHILE MAINTAINING THE TARGET TEMPERATURE, IT WAS OBSERVED THAT THE 500-ML SALINE BAG WAS PARTIALLY DEPLETED, AND THE PATIENT'S NECK BECAME INCREASINGLY SWOLLEN AT THE CATHETER INSERTION SITE. THERE WAS NO SALINE EVIDENCE ON THE PATIENT'S BED, THE THERMOGARD CONSOLE, OR THE FLOOR. THE PATIENT HAD BEEN REPOSITIONED ONCE IN THE CARDIAC CATHETERIZATION LAB (CATH LAB) THREE DAYS PRIOR TO THE INCIDENT. NO SUBCUTANEOUS DRUG INFUSION WAS SUSPECTED; HOWEVER, A 50 ML SALINE INFILTRATION WAS SUSPECTED. THE CATHETER WAS REMOVED AFTER 96 HOURS OF DWELL TIME, AND THERAPY WAS DISCONTINUED. A COLD PACK WAS APPLIED TO REDUCE THE SWELLING. THE SWELLING EVENTUALLY SUBSIDED, BUT IT IS UNCLEAR WHETHER THIS WAS DUE TO THE COLD PACK OR A NATURAL PROGRESSION OVER TIME. THE PATIENT REMAINED SEDATED, INTUBATED, AND HEMODYNAMICALLY STABLE. A LEAK TEST WAS PERFORMED VIA PHONE CONSULTATION WITH THE ZOLL TERRITORY MANAGER, FOLLOWING ZOLL'S INSTRUCTIONS FOR USE (IFU). HOWEVER, NO SALINE LEAKAGE WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079719 SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. SL-2593AE 206518 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other