BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 16397988 · Received February 17, 2023

    Report

    Report Number
    3010617000-2023-00155
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 22, 2023
    Report Date
    June 15, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075527
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEEMS THAT AROUND 200ML OF STERILE COLD SALINE WAS ENTERED THE PATIENT'S VASCULATURE. ADMINISTRATION OF STERILE COLD SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS AND SHOULD NOT HARM A PATIENT.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK ON THE ICY CATHETER (LOT # 181290) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE COULD BE A LATENT DEFECT AT THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. BLOOD RESIDUES WERE OBSERVED IN THE MEDIAL LUERED TUBING. A FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER UP TO 100PSI, A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL 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 NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR A QUATTRO CATHETER WITH LOT NUMBER 181290. SEEMS THAT AROUND THREE 200ML OF STERILE COLD SALINE WAS ENTERED THE PATIENT'S VASCULATURE. ADMINISTRATION OF STERILE COLD SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS AND SHOULD NOT HARM A PATIENT. THE FLUID RAN INTO THE PATIENT'S VASCULATURE IS AN ANTICIPATED EVENT. THE EVENT OF THE CATHETER LEAK RELATIONSHIP TO THE DEVICE AND THE PROCEDURE IS CASUAL. THE PATIENT'S DEATH IS NOT RELATED TO A STUDY DEVICE BUT RELATED TO A POST CARDIAC ARREST CLINICAL CONDITION. OUT-OF-HOSPITAL CARDIAC ARREST (OHCA) IS ONE OF THE MAIN CAUSES OF DEATH IN INDUSTRIAL NATIONS. ABOUT 25% OF PATIENTS SURVIVE THIS EVENT AND MAKE IT TO THE HOSPITAL, AND EVEN FEWER PATIENTS SURVIVE AFTER 24 HOURS (NICHOL, NEJM, 2015). IN THE UNITED STATES, SURVIVAL TO HOSPITAL DISCHARGE AFTER NON-TRAUMATIC EMERGENCY MEDICAL SERVICES-TREATED CARDIAC ARREST WITH ANY FIRST RECORDED RHYTHM WAS 10.6% FOR PATIENTS OF ANY AGE. OF THE BYSTANDER-WITNESSED OUT-OF-HOSPITAL CARDIAC ARRESTS IN 2011, 31.4% OF VICTIMS SURVIVED TO HOSPITAL DISCHARGE (MOZAFFARIAN, CIRCULATION, 2016). DEATH IS AN EXPECTED OUTCOME FOR OHCA. DEATH IS AN ANTICIPATED EVENT. THE EVENT OF DEATH IS NOT RELATED TO THE DEVICE AND THE PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2023 AT 12:50 PM, A CARDIOPULMONARY ARREST (CPA) PATIENT (81 YEARS OLD FEMALE) WITH A TEMPERATURE OF 28.7°C WAS BROUGHT TO THE HOSPITAL. THE IVTM THERAPY USING AN ICY CATHETER (LOT # 181290) BEGAN AT 1:37 PM. ON (B)(6) 2023, AT 0:15 AM, DURING THE WARMING PHASE OF THE TREATMENT, AN AIR TRAP ALARM WENT OFF AND THE DEVICE WAS PAUSED. THE CUSTOMER DISCOVERED THAT THE SALINE BAG WAS NEARLY EMPTY (ABOUT 200ML OF SALINE HAD BEEN INFUSED) AND THERE WAS A BACKFLOW OF BLOOD IN THE START-UP KIT (SUK) (LOT # 182403), CONFIRMING THE CATHETER LEAK. THE CUSTOMER DECIDED TO REMOVE THE CATHETER, HOWEVER, THE REASON FOR NOT CONTINUING THE IVTM THERAPY WAS NOT PROVIDED. AT 1:13 PM, THE CUSTOMER CONFIRMED THE PATIENT'S DEATH. AT THE TIME OF DEATH, THE PATIENT HAD A FEVER OF MORE THAN 39°C. THE REQUEST FOR ADDITIONAL INFORMATION RECEIVED LIMITED RESPONSE. THE RELATIONSHIP BETWEEN THE CATHETER LEAK AND DEATH IS UNKNOWN. THE CONSOLE WAS VERIFIED TO BE FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116267 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 181290 00849111075527

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female