BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 11136837 · Received January 7, 2021

    Report

    Report Number
    3010617000-2021-00019
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 15, 2020
    Report Date
    September 23, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADMINISTRATION OF STERILE COLD SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS AND SHOULD NOT HARM A PATIENT. THE CUSTOMER COULD BENEFIT FROM RE-TRAINING ON ACTIONS REQUIRED WHEN CATHETER LEAK IS SUSPECTED TO AVOID JUST CHANGING SALINE BAGS. THE FLUID RAN INTO THE PATIENT'S VASCULATURE IS AN ANTICIPATED EVENT. NO PATIENT'S EFFECT WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE ICY CATHETER (LOT # 143083) LEAK WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A BONDING LEAK WAS NOTICED AT THE PROXIMAL END OF THE MEDIAL BALLOON. THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO A LATENT DEFECT AT THE BOND. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. NOTICED BLOOD RESIDUE IN THE DISTAL 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 PROXIMAL END OF THE MEDIAL BALLOON. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING THE 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 143083.

    Additional Manufacturer Narrative · 1

    THE ZOLL ICY CATHETER WAS NOT RETURNED TO ZOLL FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PER THE REPORTER, THE ICY CATHETER WAS PLACED IN THE LEFT FEMORAL VEIN FOR THE IVTM TREATMENT OF THE POST-CARDIAC ARREST PATIENT WITH NO FAILED ATTEMPTS. THE PLACEMENT WAS SMOOTH AND GUIDED WITH THE ULTRASOUND. THE PATIENT'S INITIAL TEMPERATURE WAS 37.9°C WITH A TARGET OF 34-36°C. DURING THE REWARMING PHASE, TWO DAYS AFTER THE TREATMENT STARTED, THE BEDSIDE NURSE NOTICES AN EMPTY SALINE BAG. THE PATIENT'S TEMPERATURE WAS 37.7°C. THE BAG WAS REPLACED AND THE CATHETER LUMENS WERE INSPECTED. AFTER AN UNSPECIFIED PERIOD, THE USER NOTICED AN ALMOST EMPTY SALINE BAG AGAIN. NO LEAK WAS OBSERVED BY THE CATHETER LUMEN LINES OR IN THE CONSOLE. SUSPECTING ICY CATHETER LEAK AND APPROXIMATELY 750 ML OF SALINE INFUSION. PER THE REPORTER, THE CATHETER WAS REMOVED, AND THE PATIENT ACHIEVED TARGET TEMPERATURE WITH A COOLING BLANKET. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30645 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 143646 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1