BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 10518156 · Received September 10, 2020

    Report

    Report Number
    3010617000-2020-00897
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 14, 2020
    Report Date
    September 10, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075527
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "THE ICY CATHETER (LOT # 142550) LEAK" WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED CATHETER. A WATER EMISSION/LEAK WAS OBSERVED FROM THE PROXIMAL INFUSION LUMEN OPENING AND FROM THE PROXIMAL LUER DURING LUMEN CROSSTALK TEST. THE PROBABLE ROOT CAUSE IS WEAKENED WALL BETWEEN THE LUMENS, WHICH SURVIVED PRESSURE TESTING DURING MANUFACTURING BUT RESULTED IN A LEAK DURING THE USE. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE TO THE CATHETER WAS OBSERVED. NOTICED SYRINGE ATTACHED TO THE IN LUER. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION DEVICE AND UPON PRESSURIZING THE CATHETER, NO LEAK WAS OBSERVED FROM THE CATHETER BALLOONS. THE CUSTOMER'S REPORTED COMPLAINT OF " A PINHOLE LEAK FROM ONE OF THE BALLOONS" WAS NOT CONFIRMED; HOWEVER, A WATER EMISSION/LEAK WERE OBSERVED FROM THE PROXIMAL INFUSION LUMEN OPENING AND FROM THE PROXIMAL LUER DURING LUMEN CROSSTALK TEST. 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 ICY CATHETER WITH LOT NUMBER 142550.

    Description of Event or Problem · 0

    ON THE THIRD DAY OF IVTM THERAPY, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM AND THE USER NOTICED THAT THE SALINE BAG WAS EMPTY. IT WAS SUSPECTED THAT THE ICY CATHETER (LOT #142550) WAS LEAKING. SINCE THE REWARMING PHASE OF THE THERAPY HAD BEEN COMPLETED, THE CATHETER WAS REMOVED. AFTER REMOVING THE CATHETER, THE USER FLUSHED THE CATHETER BALLOONS WITH SALINE AND NOTICED A PINHOLE LEAK FROM ONE OF THE BALLOONS. IT WAS SUSPECTED THAT THE REMAINING OF THE 500-ML SALINE BAG, AFTER THE SYSTEM SET-UP, HAD INFUSED INTO THE PATIENT'S BODY. NO DEVICE MALFUNCTION WAS REPORTED ON THE TGXP CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF "THE ICY CATHETER (LOT # 142550) LEAK" WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED CATHETER. A WATER EMISSION/LEAK WAS OBSERVED FROM THE PROXIMAL INFUSION LUMEN OPENING AND FROM THE PROXIMAL LUER DURING LUMEN CROSSTALK TEST. THE PROBABLE ROOT CAUSE OF THE OBSERVED LEAK COULD BE A LATENT MATERIAL DEFECT. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE TO THE CATHETER WAS OBSERVED. NOTICED SYRINGE ATTACHED TO THE IN LUER. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION DEVICE AND UPON PRESSURIZING THE CATHETER, NO LEAK WAS OBSERVED FROM THE CATHETER BALLOONS. THE CUSTOMER'S REPORTED COMPLAINT OF " A PINHOLE LEAK FROM ONE OF THE BALLOONS" WAS NOT CONFIRMED; HOWEVER, A WATER EMISSION/LEAK WERE OBSERVED FROM THE PROXIMAL INFUSION LUMEN OPENING AND FROM THE PROXIMAL LUER DURING LUMEN CROSSTALK TEST. 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 ICY CATHETER WITH LOT NUMBER 142550.

    Description of Event or Problem · 1

    ON THE THIRD DAY OF IVTM THERAPY, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM AND THE USER NOTICED THAT THE SALINE BAG WAS EMPTY. IT WAS SUSPECTED THAT THE ICY CATHETER (LOT #142550) WAS LEAKING. SINCE THE REWARMING PHASE OF THE THERAPY HAD BEEN COMPLETED, THE CATHETER WAS REMOVED. AFTER REMOVING THE CATHETER, THE USER FLUSHED THE CATHETER BALLOONS WITH SALINE AND NOTICED A PINHOLE LEAK FROM ONE OF THE BALLOONS. IT WAS SUSPECTED THAT THE REMAINING OF THE 500-ML SALINE BAG, AFTER THE SYSTEM SET-UP, HAD INFUSED INTO THE PATIENT'S BODY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978896 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 142550 00849111075527

    Patients

    Seq Age Sex Outcome Treatment
    1