BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 3900761 · Received June 27, 2014

    Report

    Report Number
    3003793491-2014-00300
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    February 8, 2013
    Report Date
    July 31, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED ICY CATHETER CONFIRMED THE CUSTOMER'S REPORTED EVENT. THE OCCLUSION WAS CAUSED BY A SMALL PLASTIC PARTICULATE THAT PREVENTED THE CATHETER FROM INFLATING. PLEASE NOTE THAT DURING MANUFACTURING, ALL ICY-3 CATHETERS ARE 100% INSPECTED FOR LEAKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO COOLING CAPACITY USING THE THERMOGARD XP CONSOLE. THE CONSOLE WAS NOT IN STANDBY MODE. CUSTOMER REPORTED THAT THE ZOLL ICY CATHETER WAS DISCONNECTED FROM THE START UP KIT (SUK) TO CHECK THE INTEGRITY OF THE CATHETER. A STERILE SYRINGE WAS FILLED WITH STERILE SALINE AND INFUSED INTO THE CATHETER. HOWEVER, THE BALLOON COULD NOT BE FILLED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377221 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0657-01 35076

    Patients

    Seq Age Sex Outcome Treatment
    1