BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 12230306 · Received July 27, 2021

    Report

    Report Number
    3010617000-2021-00642
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 26, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF "THE USER OBSERVED EMPTY SALINE BAG DURING THE IVTM THERAPY USING THE QUATTRO CATHETER (LOT # 141854)" WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER. A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED INSIDE OF THE MEDIAL AND PROXIMAL LUERED TUBINGS. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A PINHOLE 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 COMPLAINTS REPORTED FOR QUATTRO CATHETER WITH LOT NUMBER 141854.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT IVTM THERAPY AFTER OUT-OF-HOSPITAL CARDIAC ARREST (OHCA). A QUATTRO CATHETER (LOT # 141854) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED. THERE WERE NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE TREATMENT WAS 35.9° C, AND THE TARGET TEMPERATURE WAS SET AT 33.0 °C ON THE MAX RATE. ABOUT 2 HOURS AFTER STARTING THE TREATMENT, THE THERMOGARD CONSOLE DISPLAYED AN "AIR TRAP" ALARM. FOLLOWING THE ALARM, THE 500-ML SALINE BAG WAS OBSERVED EMPTY. THE PATIENT'S BODY TEMPERATURE WAS AT 33.0°C WHEN THE ISSUE OCCURRED. UPON INSPECTION, THERE WAS NO FLUID OBSERVED ON THE PATIENT'S BED, THE THERMOGARD CONSOLE, OR THE FLOOR. INFUSION OF ABOUT 250 MILLILITERS OF SALINE INTO THE PATIENT'S BODY WAS SUSPECTED. THE CATHETER WAS REMOVED, AND THE "AIR TRAP" ALARM WAS CLEARED. AFTER REPLACING THE CATHETER, THE THERAPY WAS CONTINUED AND COMPLETED WITH THE SAME THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125801 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE 141854 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR