BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM XXXX CATHETER

    MDR report key: 6018699 · Received October 11, 2016

    Report

    Report Number
    3010617000-2016-00715
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 4, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ICY CATHETER (LOT # 64101) WAS RETURNED TO ZOLL (B)(4) FOR EVALUATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WERE NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR ICY CATHETER LOT # 64101. A VISUAL INSPECTION OF THE RETURNED CATHETER FOUND BLOOD HAD ACCUMULATED /DRIED UP ON THE BALLOONS, SHAFT, LUERED TUBINGS AND INFUSION PORTS. BALLOON TEAR WAS OBSERVED AT THE MEDIAL BALLOON. FUNCTIONAL TESTING WAS PERFORMED AND DURING FLUSHING OF THE CATHETER, A LEAK WAS OBSERVED AT THE MEDIAL BALLOON. THE RETURNED CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. IMMEDIATELY AFTER PRESSURIZING THE CATHETER, A BALLOON LEAK WAS FOUND AT THE MEDIAL BALLOON. EVALUATION OF THE RETURNED ICY CATHETER CONFIRMED THE CUSTOMER REPORTED ISSUE AS A TORN BALLOON AT THE MEDIAL BALLOON. NOTE, DURING MANUFACTURING, ALL ICY CATHETERS ARE 100% INSPECTED FOR LEAKS. IN ADDITION, EXTENSION TUBING IS ALSO 100% TESTED FOR LEAKS. ONLY UNITS THAT PASS THE TESTING ARE MOVED TO THE NEXT PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT WEIGHING (B)(6) WHO CODED AFTER HAVING CARDIOGENIC SHOCK AND SEPTIC. PATIENT'S HISTORY INCLUDED CAD, COPD, AND PULM HTN. BLOOD COAGS WAS NOT AVAILABLE PRIOR TO IVTM. A ZOLL ICY CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN AND AN INSERTION WAS NOT DIFFICULT. THE PATIENT'S INITIAL TEMPERATURE WAS 36.9°C WITH A TARGET TEMPERATURE OF 33°. BLOOD WAS OBSERVED IN COOLING LINE AND BLOOD WAS BACKING INTO LINE. IT'S UNKNOWN WHEN THE LEAK WAS DISCOVERED. IT WAS UNSAFE FOR THE PATIENT AND THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668413 ZOLL IVTM XXXX CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0697 64101 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR