BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 15295955 · Received August 25, 2022

    Report

    Report Number
    3010617000-2022-01260
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    July 23, 2022
    Report Date
    August 25, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "THE CUSTOMER REPLACED THE 500ML SALINE BAG" WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT DISTAL END OF THE MEDIAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE REPORTED LEAK WAS DUE TO A LATENT DEFECT AT THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. OBSERVED BLOOD RESIDUES IN THE BALLOONS AND LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED, AN ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE ICY CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER UP TO 100 PSI, A BONDING LEAK WAS OBSERVED AT DISTAL END OF MEDIAL 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 WERE 3 SIMILAR COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 169512. (B)(6) , REPORTED ON MAR 16, 2022, (B)(6) , REPORTED ON JUN 15, 2022, (B)(6) REPORTED ON JUL 08, 2022, A BALLOON BOND LEAK WAS OBSERVED.

    Description of Event or Problem · 0

    AT AROUND THE 6TH DAY OF THE MAINTENANCE PHASE AFTER TARGET TEMPERATURE WAS ACHIEVED AT 34 DEGREES, THE CUSTOMER OBSERVED SALINE TRACES ON THE FLOOR AND THE THERMOGARD IVTM SYSTEM DISPLAYED AN "AIR TRAP WARNING" MESSAGE. THE TOP CAP ON THE AIR TRAP OF THE START-UP KIT (SUK) (LOT #170394) WAS FOUND DETACHED. THE SUK WAS REPLACED, A NEW SALINE BAG WAS PLACED AND TREATMENT CONTINUED WITH SAME THERMOGARD IVTM SYSTEM. A DAY LATER, THE THERMOGARD IVTM SYSTEM DISPLAYED AN "AIR TRAP WARNING" MESSAGE AND THE CUSTOMER REPLACED THE 500ML SALINE BAG. SIX HOURS LATER, THE THERMOGARD IVTM SYSTEM DISPLAYED AN "AIR TRAP WARNING" MESSAGE AGAIN. THE CUSTOMER REPLACED THE ICY CATHETER (LOT #169512) WITH A NEW CATHETER AND CONTINUED WITH TREATMENT WITHOUT ANY ISSUES. THE "AIR TRAP WARMING" MESSAGE WAS CLEARED FROM THE THERMOGARD IVTM SYSTEM AND WAS USED TO COMPLETE THE TREATMENT. THE ICY CATHETER INSERTION WAS SMOOTH INTO THE PATIENT'S LEFT FEMORAL VEIN. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102096 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 169512 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown