BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 10019458 · Received May 1, 2020

    Report

    Report Number
    3010617000-2020-00421
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 8, 2020
    Report Date
    June 25, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAKING QUATTRO CATHETER (LOT #140485) NEAR THE 42CM MARKER ON THE CATHETER SHAFT WAS CONFIRMED DURING FUNCTIONAL TESTING. A LEAK IN THE CATHETER SHAFT WAS OBSERVED AT 5 CM AWAY FROM THE DISTAL END OF MANIFOLD (42CM MARKER ON THE SHAFT). UNDER MICROSCOPE, A SMALL SHARP CUT WHERE THE LEAK WAS OBSERVED. THEREFORE, THE ROOT CAUSE IS THE CUT APPEARS TO BE CONSISTENCE WITH THE CUT MADE BY A SHARP TOOL.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF A LEAKING QUATTRO CATHETER (LOT #140485) NEAR THE 42CM MARKER ON THE CATHETER SHAFT WAS CONFIRMED DURING FUNCTIONAL TESTING. A LEAK IN THE CATHETER SHAFT WAS OBSERVED AT 5 CM AWAY FROM THE DISTAL END OF MANIFOLD (42CM MARKER ON THE SHAFT). UNDER MICROSCOPE, A SMALL SHARP CUT WHERE THE LEAK WAS OBSERVED. THEREFORE, THE PROBABLE ROOT CAUSE OF THE LEAKING CATHETER WAS LIKELY DUE TO USER ERROR, CATHETER MAY HAVE BEEN INADVERTENTLY CUT BY A SHARP MEDICAL TOOL. VISUAL INSPECTION OF THE RETURNED QUATTRO CATHETER WAS PERFORMED. THE BALLOONS WERE EXAMINED AND THERE WERE NO TEARS, BALLOON BOND DETACHMENT OR RUPTURE NOTED. DRIED BLOOD RESIDUE WAS OBSERVED ON THE BALLOONS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE AND IMMEDIATELY A LEAK IN THE CATHETER SHAFT WAS OBSERVED. THUS, CONFIRMING THE REPORTED COMPLAINT. 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. THEREFORE, THE QUATTRO CATHETER ASSOCIATED WITH THIS EVENT WAS NOT DEFECTIVE WHEN SHIPPED. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR QUATTRO CATHETER WITH LOT NUMBER 140485. ZOLL MEDICAL SAFETY ASSESSMENT: OUTCOME OF DEATH WAS SERIOUS. BECAUSE OF THE POOR PROGNOSIS, THE PATIENT WAS WITHDRAWN FROM THE THERAPY. THE PATIENT DIED DUE TO THE POOR STARTING SITUATION. INSERTION OF 1000 ML OF STERILE SALINE OVER 2H IN THE PATIENT'S VASCULATURE COULD NOT POTENTIALLY HARM THE PATIENT. ADMINISTRATION OF STERILE COLD SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS. IN AGREEMENT WITH A CUSTOMER, THE PATIENT'S DEATH WAS NOT ATTRIBUTED ZOLL CATHETER.

    Description of Event or Problem · 1

    DURING PATIENT USE, CUSTOMER REPORTED THAT DURING THE FIRST 2 HOURS OF THERAPY, TWO 500 ML. SALINE BAGS HAD EMPTIED. AFTER THE FIRST SALINE BAG WAS REPLACED, NO SALINE FLUIDS WERE OBSERVED ON PATIENT'S BED, FLOOR NOR THERMOGARD XP IVTM SYSTEM. THE SAME ISSUE HAPPENED AGAIN WITH THE SECOND SALINE BAG. THE PHYSICIAN SUSPECTED A CATHETER LEAK. THERMOGARD IVTM SYSTEM ALARMED AND DISPLAYED "AIR TRAP" BUT WAS LATER CLEARED. UPON SEEING THE 2ND EMPTY SALINE BAG, THE PHYSICIAN STOPPED THE TREATMENT DUE TO THE PATIENT'S POOR PROGNOSIS. THE PATIENT EXPIRED. THE QUATTRO CATHETER WAS INSERTED IN THE PATIENT'S LEFT SIDE FEMORAL VEIN BY AN EXPERIENCED PHYSICIAN, WITH NO DIFFICULTY. THE PHYSICIAN REMOVED THE QUATTRO FROM THE PATIENT AND OBSERVED LEAK NEAR THE 42CM MARKER ON THE CATHETER SHAFT. THE PATIENT WAS IN THERAPY DUE TO POST CARDIAC ARREST WITH A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND HYPERTENSION. ACCORDING TO THE HOSPITAL, THE PATIENT OUTCOME WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481771 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE 140485 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death