BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 13518962 · Received February 11, 2022

    Report

    Report Number
    3010617000-2022-00132
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    January 3, 2022
    Report Date
    February 11, 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 LEAK ON THE ICY CATHETER (LOT # 162799) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE PROXIMAL BALLOON AND ALSO 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, NO PHYSICAL DAMAGE WAS OBSERVED. DRIED BLOOD RESIDUE WAS OBSERVED ON THE CATHETER'S BALLOONS. 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 DISTAL END OF THE PROXIMAL BALLOON AND ALSO 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 AN ICY CATHETER WITH LOT NUMBER 162799. CCR 59817 WAS REPORTED ON (B)(6) 2021 AND A BOND LEAK WAS CONFIRMED.

    Description of Event or Problem · 0

    AFTER SIX HOURS OF AN IVTM TREATMENT, THE CUSTOMER NOTICED A LEAK AT THE START-UP KIT (SUK) (LOT# UNKNOWN). THE SUK WAS REPLACED, HOWEVER, WITHIN AN HOUR, THE CONSOLE GENERATED AN AIR TRAP ALARM, BUT THE USER DID NOT NOTICE ANY VISIBLE SIGNS OF AN EXTERNAL SALINE LEAK. THE CUSTOMER SUSPECTED A CATHETER LEAK. THE USER REPLACED THE ICY CATHETER (LOT # 162799) TO CONTINUE THE TREATMENT UTILIZING THE SAME CONSOLE. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119423 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 162799 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown