BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14740100 · Received June 19, 2022

    Report

    Report Number
    3010617000-2022-00680
    Event Type
    Malfunction
    Date Received
    June 19, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 18, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    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 SALINE BAG EMPTY WHILE USING THE ICY CATHETER (LOT # 162799) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL BALLOON. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD BE A LATENT DEFECT AT THE BOND. UPON VISUAL INSPECTION, OBSERVED THE CATHETER SHAFT WAS KINKED AT 6.5 IN AWAY FROM THE CATHETER TIP. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED, HOWEVER, IMPROPER HANDLING OF THE CATHETER CANNOT BE RULED OUT. IN ADDITION, THE DRIED BLOOD RESIDUE WAS OBSERVED ON THE CATHETER'S BALLOONS AND LUERED TUBING. 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, 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 ARE THREE SIMILAR COMPLAINTS REPORTED FOR AN ICY CATHETER WITH LOT NUMBER 162799. CCR 59817, REPORTED ON (B)(6) 2021, CCR 63140, REPORTED ON (B)(6) 2022, AND CCR 63141, REPORTED ON (B)(6) 2022, BONDING LEAK WAS CONFIRMED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING IVTM THERAPY THE ICY CATHETER (LOT # 162799) WAS PLACED IN THE PATIENT'S VEIN. AFTER AN UNKNOWN PERIOD OF TIME, THE CUSTOMER NOTICED A SALINE BAG EMPTY WITH NO EXTERNAL LEAKS AS THERE WAS NO EVIDENCE OF SALINE ON THE FLOOR OR BED. PER THE REPORTER, NO SWELLING WAS NOTED AROUND THE CATHETER INSERTION SITE. THE CATHETER LEAK AND INFUSION OF AN UNKNOWN AMOUNT OF SALINE FLUID INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. NO FURTHER INFORMATION WAS PROVIDED IF A NEW CATHETER WAS USED TO CONTINUE THE THERAPY OR IF AN ALTERNATIVE TEMPERATURE THERAPY WAS UTILIZED. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350586 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 162799 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown