BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 15172763 · Received August 5, 2022

    Report

    Report Number
    3010617000-2022-00981
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 4, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK ON THE ICY CATHETER (LOT # 169512) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE COULD BE A LATENT DEFECT AT THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. BLOOD RESIDUES WERE OBSERVED ON THE BALLOONS AND LUERED TUBINGS. A FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER UP TO 100PSI, A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE 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 WAS ONE SIMILAR COMPLAINT REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 169512. CCR 64866, REPORTED ON MAR 16, 2022. A BALLOON BOND LEAK WAS NOTED DUE TO A LATENT DEFECT AT THE BOND. SEEMS THAT AROUND 1000 ML OF STERILE COLD SALINE WAS ENTERED THE PATIENT'S VASCULATURE. ADMINISTRATION OF STERILE COLD SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT HOSPITALS AND SHOULD NOT HARM A PATIENT. THE CUSTOMER WILL BENEFIT FROM ADDITIONAL TRAINING ON HOW TO HANDLE SUSPECTED CATHETER LEAK. THE FLUID RAN INTO THE PATIENT'S VASCULATURE IS AN ANTICIPATED EVENT. BASED ON AVAILABLE INFORMATION, NO PATIENT'S EFFECT WAS OBSERVED. THE EVENT'S RELATIONSHIP TO THE DEVICE AND PROCEDURE IS CASUAL.

    Description of Event or Problem · 0

    THE PATIENT WAS HOSPITALIZED POST-CARDIAC ARREST AND UNDERWENT THERAPEUTIC HYPOTHERMIA. THE ICY CATHETER (LOT # 169512) WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN. SEVERAL HOURS AFTER THE CATHETER PLACEMENT, THE NURSE NOTED AN EMPTY SALINE BAG. THERE WERE NO TRACES OF FLUID OBSERVED AROUND THE CONSOLE, PATENT BED, OR START-UP KIT (SUK) (LOT# 170014) TUBING. THE NURSE REPLACED THE SALINE BAG, HOWEVER, A FEW HOURS LATER, THE BAG WAS NOTED EMPTY. A CATHETER LEAK AND THE INFUSION OF AN UNKNOWN AMOUNT OF SALINE FLUID WERE SUSPECTED. THE ICY CATHETER WAS NOT REPLACED AS THE PATIENT WAS IN THE NORMOTHERMIA PHASE. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING THE LEAK CHECK AND THE CONSOLE ALARM. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519628 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 169512 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown