BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 11198723 · Received January 19, 2021

    Report

    Report Number
    3010617000-2021-00037
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 27, 2020
    Report Date
    January 22, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    THE ICY CATHETER (LOT # 150139) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED, AND NO PUMP OR ANY PRESSURIZED DEVICE WAS USED FOR INFUSION. A COUPLE OF MINUTES AFTER THE CATHETER WAS INSERTED, BLOOD TINGE WAS OBSERVED IN THE SUK TUBING. BALLOON LEAK AND INFUSION OF A FEW AMOUNT OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THERE WERE NO TRACES OF FLUID OBSERVED ON THE CONSOLE, PATIENT'S BED, OR FLOOR. THE CATHETER WAS REPLACED, AND THE TREATMENT WAS COMPLETED SUCCESSFULLY WITH THE SAME CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE ICY CATHETER (LOT #150139) WAS RETURNED DAMAGED, AND THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, BLOOD WAS OBSERVED INSIDE THE PROXIMAL LUERED TUBING AND INSIDE OF THE BALLOONS; THIS TYPICALLY IS INDICATIVE OF A LEAK SOMEWHERE IN THE CATHETER. SPECIFIC LOCATION OR TYPE OF LEAK IS UNDETERMINED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RECEIVED. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED. THE CATHETER SHAFT WAS COMPLETELY CUT OFF AT 3 CM AWAY FROM THE DISTAL END OF THE MANIFOLD. THE SHAFT WAS CUT BY THE PHYSICIAN TO ENHANCE THE PLACEMENT OF THE NEW ICY CATHETER. BLOOD WAS OBSERVED IN THE CATHETER BALLOONS AND IN THE PROXIMAL LUERED TUBING. NO TEARS, BALLOON BOND DETACHMENT, OR RUPTURE WERE NOTED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RETURNED. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    THE ICY CATHETER (LOT #150139) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED. AFTER A COUPLE OF MINUTES, BLOOD TINGE WAS OBSERVED IN THE SUK TUBING. THE USER SUSPECTED A CATHETER LEAK DUE TO A POTENTIAL BALLOON RUPTURE, AND INFUSION OF A FEW AMOUNT OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THERE WERE NO TRACES OF FLUID OBSERVED ON THE CONSOLE, PATIENT'S BED, OR FLOOR. THE CATHETER WAS REPLACED, AND THE TREATMENT WAS COMPLETED SUCCESSFULLY WITH THE SAME CONSOLE. AS REPORTED, THE PHYSICIAN DID NOT USED A PUMP OR ANY PRESSURIZED DEVICE FOR INFUSION. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89125 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 150139 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1