BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 12702032 · Received October 27, 2021

    Report

    Report Number
    3010617000-2021-00968
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK ON THE ICY CATHETER (LOT # 162799) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE PROXIMAL BALLOON. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD BE A LATENT DEFECT AT THE BOND. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. DRIED BLOOD RESIDUE WAS OBSERVED IN THE CATHETER'S BALLOONS AND MEDIAL LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER, A BOND LEAK WAS OBSERVED AT THE DISTAL END OF THE PROXIMAL BALLOON, THUS 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 COMPLAINT REPORTED FOR A CATHETER WITH LOT NUMBER 162799.

    Additional Manufacturer Narrative · 1

    THE ZOLL ICY CATHETER WAS RETURNED TO ZOLL FOR EVALUATION, HOWEVER, THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED POST-CARDIAC ARREST AND UNDERWENT THERAPEUTIC HYPOTHERMIA. AN ICY CATHETER (LOT # 162799) WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN, THE INSERTION WAS SMOOTH FROM THE FIRST ATTEMPT. THE PATIENT'S TEMPERATURE AT THE TIME OF ISSUE WAS 36.5°C. THE PATIENT'S BODY TEMPERATURE WAS MEASURED AT 33°C BEFORE THE REWARMING PHASE STARTED. 48 HOURS AFTER THE CATHETER INSERTION, THE USER NOTICED THAT THE SALINE BAG WAS ALMOST EMPTY AND THE CONSOLE DID NOT GENERATE THE AIR TRAP ALARM AS THE LOW SALINE LEVEL WAS NOTED BY THE USER BEFORE THE AIR TRAP ALARM MESSAGE. THERE WERE NO TRACES OF FLUID OBSERVED ON THE PATIENT'S BED, FLOOR, OR CONSOLE. THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. A CATHETER LEAK AND THE INFUSION OF THE 200ML OF SALINE FLUID WERE SUSPECTED. THE USER REPLACED THE CATHETER TO CONTINUE THE TREATMENT. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606038 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 162799 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown