BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 6998003 · Received November 2, 2017

    Report

    Report Number
    3010617000-2017-00866
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075237
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CATHETER CONFIRMED THE CUSTOMER REPORTED COMPLAINT AS AN ICY CATHETER BOND LEAK BETWEEN THE MEDIAL AND DISTAL BALLOONS. DURING MANUFACTURING ALL ICY CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. PROBABLE CAUSES FOR THE REPORTED COMPLAINT WERE A LATENT DEFORMITY IN THE BOND, WHICH RESULTED IN EVENTUAL LEAK UNDER PRESSURE, OR A BOND DELAMINATION INCURRED DURING CATHETER PLACEMENT. VISUAL INSPECTION FOUND NO VISUAL DISCREPANCIES OR ISSUES. ALL LUMENS FLUSHED AS INTENDED. NO LEAKS WERE NOTICED DURING FLUSHING. DURING FUNCTIONAL TESTING, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. CAPPING THE "OUT" LUER AND CONNECTING THE "IN" LUER TO THE PRESSURE INFLATION DEVICE. IMMEDIATELY UPON PRESSURING THE CATHETER, A LEAK PATH WAS IDENTIFIED AT THE BOND BETWEEN THE MEDIAL AND DISTAL BALLOONS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF RELATED COMPLAINTS FOR ICY CATHETER LOT # 71718.

    Additional Manufacturer Narrative · 1

    THE ZOLL CATHETER WAS RETURNED TO ZOLL ON (B)(6) 2017 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A PATIENT WAS HOSPITALIZED POST CARDIAC ARREST AND INTRAVASCULAR TEMPERATURE MANAGEMENT WAS NEEDED FOR THERAPEUTIC HYPOTHERMIA. A ZOLL ICY CATHETER WAS INSERTED INTO THE FEMORAL VEIN BY AN EXPERIENCED PHYSICIAN. THE INDWELL TIME OF THE CATHETER WAS 12-24 HOURS. THE ATTENDING NURSE NOTED THAT THE SALINE BAG EMPTIED AND NOTIFIED THE PHYSICIAN. THE PHYSICIAN INSTRUCTED THE ATTENDING NURSE TO REPLACE THE SALINE BAG. THE SALINE BAG WAS REPLACED; HOWEVER, CONTINUED TO EMPTY AT APPROXIMATELY 100 CC/ HR. ZOLL CLINICAL TEAM ADVISED THE ATTENDING NURSE THAT ZOLL RECOMMENDATIONS ARE TO DISCONNECT THE CATHETER AND REPLACE EITHER OVER GUIDE WIRE OR NEW INSERTION SITE. THE ATTENDING NURSE STATED THAT PHYSICIAN IS AWARE OF RECOMMENDATIONS AND RISKS OF LEAVING CATHETER IN PATIENT WITH A LEAK. AT THE TIME OF CALL, CATHETER IS CONTINUING TO BE USED AND PATIENTS TEMP IS BEING MAINTAINED AT 34 DEGREE CELSIUS. THE PHYSICIAN IS NOT WORRIED ABOUT "EXTRA FLUID" PATIENT IS RECEIVING. ZOLL CLINICAL TEAM HAS ADVISED THE ATTENDING NURSE TO KEEP VERY CLOSE EYE ON SALINE BAG FOR RAPID INFUSION OF THE REST OF THE BAG. PATIENT HAS RECEIVED AN ADDITIONAL 400CCS FROM LITER BAG IN 5 HOURS. THE CATHETER WAS NOT REMOVED AND THE CUSTOMER WAS ABLE TO REWARM THE PATIENT WITH THE CATHETER WITHOUT ANY DIFFICULT. THE CATHETER WAS REMOVED ON MONDAY (B)(6) 2017. THE ATTENDING NURSE DOES NOT KNOW HOW MANY CC'S OF SALINE THE PATIENT ENDED UP RECEIVING. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775745 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 UNKNOWN 00849111075237

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR