BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 13608049 · Received February 26, 2022

    Report

    Report Number
    3010617000-2022-00182
    Event Type
    Malfunction
    Date Received
    February 26, 2022
    Date of Event
    February 2, 2022
    Report Date
    April 26, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT "SALINE BAGS WERE RUNNING EMPTY" WAS CONFIRMED DURING FUNCTIONAL TESTING PERFORMED AT ZOLL. A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL 1 BALLOON OF THE RETURNED CATHETER. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD BE A LATENT DEFECT AT THE BOND. VISUAL EXAMINATION OF THE RETURNED QUATTRO CATHETER WAS PERFORMED AND FOUND NO PHYSICAL DAMAGE TO THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED IN THE CATHETER'S BALLOONS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES 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. UPON PRESSURIZING THE CATHETER, A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL 1 BALLOON, 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 SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE QUATTRO CATHETER WITH LOT NUMBER 143398. 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 CUSTOMER WILL BENEFIT FROM ADDITIONAL TRAINING ON HOW TO HANDLE SUSPECTED CATHETER LEAK. THE FLUID RAN INTO THE PATIENT'S VASCULATURE IS AN ANTICIPATED EVENT. BASED ON AVAILABLE INFORMATION, NO PATIENT'S EFFECT WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    A2 (PATIENT INFORMATION, AGE AT TIME OF EVENT, DATE OF BIRTH) WAS UPDATED. A3 (PATIENT INFORMATION, SEX) WAS UPDATED. B5 (DESCRIBE EVENT OR PROBLEM) WAS UPDATED. E3 (INITIAL REPORTER, OCCUPATION) WAS UPDATED.

    Description of Event or Problem · 0

    A PATIENT WAS CONNECTED TO THE THERMOGARD XP IVTM SYSTEM INCLUDING THE QUATTRO CATHETER (LOT # 143398) AND START-UP KIT (SUK) (LOT # 161544). CATHETER INSERTION WAS SMOOTH WITH NO COMPLICATIONS. APPROXIMATELY 36 HOURS AFTER THE INITIATION OF THE TREATMENT, THE NURSE HEARD AN "AIR TRAP" ALARM AND NOTICED THAT THE 500-ML SALINE BAG WAS RUNNING EMPTY. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT TO STANDBY MODE. THE NURSE REPLACED THE SALINE BAG AND RESUMED THE THERAPY. AFTER ABOUT 30 MINUTES, THE THERMOGARD CONSOLE DISPLAYED AN "AIR TRAP" ALARM AGAIN, AND THE NURSE NOTED THAT THE SECOND BAG WAS ALSO RUNNING EMPTY. THE NURSE REPLACED THE SECOND BAG, BUT AFTER ABOUT 1 HOUR, THE SAME ISSUE HAPPENED AGAIN WITH THE THIRD SALINE BAG. FOLLOWING THIS, THE NURSE INSPECTED THE SURROUNDINGS AND FOUND NO SALINE AROUND OR ON THE THERMOGARD CONSOLE, OR THE PATIENT'S BED. THE CATHETER WAS REMOVED FROM THE PATIENT AND THE TREATMENT WAS CONTINUED WITH COOLING BLANKETS, TYLENOL, AND ICE PACKS. NO INTERVENTION WAS REQUIRED TO MITIGATE A POTENTIAL RISK OF FLUID OVERLOAD, AND THE PATIENT DID NOT SHOW ANY EVIDENCE OF VOLUME OVERLOAD/SALINE INFUSION. THE CLINICAL ENGINEERING STAFF TROUBLESHOT THE ISSUE BY FLUSHING SALINE THROUGH THE CATHETER IN/OUT LUERS BUT FOUND NO ISSUES. IN ADDITION, THE CATHETER WAS FLUSHED WITH DYE TO FIND ANY POTENTIAL LEAK, AND NO LOSS OF VOLUME/DYE WAS NOTED. FURTHERMORE, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE BUT FOUND NO ISSUES. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    A PATIENT WHO HAD EXPERIENCED A MAJOR CARDIAC EVENT WAS CONNECTED TO THE QUATTRO CATHETER (LOT # 143398) AND START-UP KIT (SUK) (LOT # 161544) TO RECEIVE IVTM THERAPY. THE PATIENT WAS UNCONSCIOUS AND FEBRILE, AND THE IVTM TREATMENT STARTED TO HELP WITH TEMPERATURE CONTROL. CATHETER INSERTION WAS SMOOTH WITH NO COMPLICATIONS. APPROXIMATELY 36 HOURS AFTER THE INITIATION OF THE TREATMENT, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM, AND THE NURSE FOUND THAT THE 500-ML SALINE BAG WAS EMPTY. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT TO STANDBY MODE. THE NURSE REPLACED THE SALINE BAG AND RESUMED THE THERAPY. AFTER ABOUT 30 MINUTES, THE THERMOGARD CONSOLE DISPLAYED AN "AIR TRAP" ALARM AGAIN, AND THE SECOND SALINE BAG WAS FOUND TO BE EMPTY. THE NURSING STAFF INSPECTED THE SURROUNDINGS AND FOUND NO FLUID AROUND THE TUBINGS, ON/AROUND THE THERMOGARD CONSOLE, OR THE PATIENT'S BED TO EXPLAIN THE SALINE LOSS. THE SECOND SALINE BAG WAS ALSO REPLACED, AND THE TREATMENT CONTINUED. AFTER ABOUT AN HOUR, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM AGAIN, AND THE THIRD SALINE BAG WAS FOUND TO BE EMPTY AS WELL. AGAIN, NO SIGNS OF LEAKAGE WERE FOUND IN AND AROUND THE CATHETER, PATIENT, OR THE THERMOGARD CONSOLE. THE CATHETER WAS REMOVED FROM THE PATIENT AND THE TREATMENT WAS CONTINUED WITH COOLING BLANKETS, TYLENOL, AND ICE PACKS. NO INTERVENTION WAS REQUIRED TO MITIGATE A POTENTIAL RISK OF FLUID OVERLOAD. THE PATIENT SHOWED NO SIGNS OF HAVING ENDURED A RAPID INFUSION OF FLUID, AND THERE WERE NO SIGNS OF EDEMA AND NO INCREASED URINE OUTPUT. THE CLINICAL ENGINEERING STAFF TROUBLESHOT THE ISSUE BY FLUSHING SALINE THROUGH THE CATHETER IN/OUT LUERS BUT FOUND NO ISSUES. IN ADDITION, THE CATHETER WAS FLUSHED WITH DYE TO FIND ANY POTENTIAL LEAK, AND NO LOSS OF VOLUME/DYE WAS NOTED. FURTHERMORE, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE BUT FOUND NO ISSUES. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399715 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 143398 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male