BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 18422193 · Received December 29, 2023

    Report

    Report Number
    3010617000-2023-01097
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 29, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE SALINE SOLUTION IN THE SALINE BAG HAD DECREASED WAS CONFIRMED DURING FUNCTIONAL TESTING. DURING THE FUNCTIONAL PRESSURE LEAK TEST, A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL BALLOON OF THE RETURNED ICY CATHETER. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD BE A LATENT DEFECT IN THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER FOUND NO PHYSICAL DAMAGE. DRIED BLOOD RESIDUE WAS OBSERVED INSIDE BALLOONS AND LUER TUBINGS. DURING FUNCTIONAL TESTING, 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. UPON PRESSURIZING THE CATHETER, A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 192504.

    Description of Event or Problem · 0

    THE ICY CATHETER (LOT #192504) AND START-UP KIT (SUK) (LOT #192667) WERE USED IN INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) THERAPY. THE CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITHOUT DIFFICULTIES, AND NO NEARBY INVASIVE LINES WERE PLACED. DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, AFTER RE-WARMING THE PATIENT, THE THERMOGARD SYSTEM DISPLAYED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT INTO STANDBY MODE. UPON INSPECTION, STAFF OBSERVED A LOW SALINE LEVEL IN THE 500-ML SALINE BAG, FROTHY SALINE SOLUTION, AND AIR BUBBLES IN THE TUBING. THERE WAS NO BLOOD TINGE IN THE TUBING. SINCE THE PATIENT WAS ALREADY RE-WARMED, THE THERAPY WAS ENDED. THE DWELL TIME OF THE CATHETER WAS ABOUT TWO DAYS (FROM (B)(6) THROUGH (B)(6)). NO CONSEQUENCES OR IMPACTS ON THE PATIENT. THE ICU MANAGER LATER OBSERVED THAT THE SUK WAS NOT SPIKED PROPERLY BUT WAS UNSURE WHETHER THE LEAK WAS FROM THE CATHETER OR THE SUK. THE STAFF HAD NOT SPECIFIED IF THERE WAS SALINE ON THE FLOOR OR IN THE PATIENT'S BED TO SIGNAL IMPROPER SPIKING OF THE SALINE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742150 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 192504 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown