BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 12155937 · Received July 12, 2021

    Report

    Report Number
    3010617000-2021-00601
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 16, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    B5 (DESCRIBE EVENT OR PROBLEM) WAS UPDATED. D4 (ADDITIONAL DEVICE INFORMATION, LOT NUMBER) WAS UPDATED. H4 (DEVICE MANUFACTURE DATE) WAS UPDATED. THE REPORTED COMPLAINT OF "THE ICY CATHETER (LOT # 151767) LEAK" WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED CATHETER. A PINHOLE LEAK WAS OBSERVED AT THE MIDDLE OF THE MEDIAL 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 MIDDLE OF THE MEDIAL 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 AN ICY CATHETER WITH LOT NUMBER 151767. INFUSION OF AROUND 250 ML AMOUNT LIKELY DID NOT CONTRIBUTE TO PATIENT'S DEATH. IT IS KNOWN THAT ADMINISTRATION OF STERILE SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS. IN AGREEMENT WITH A CUSTOMER, THERE WAS NO PATIENT'S EFFECT ATTRIBUTED ZOLL CATHETER. DEATH WAS PROBABLY RELATED TO THE PATIENT'S CLINICAL CONDITION OF POST-CARDIAC ARREST. THE FLUID RAN INTO THE PATIENT'S VASCULATURE IS AN ANTICIPATED EVENT. NO PATIENT'S EFFECT WAS OBSERVED. NO PATIENT'S EFFECT (EVENT RELATED TO A DEVICE) WAS OBSERVED.

    Description of Event or Problem · 0

    A PATIENT WAS ADMITTED TO A HOSPITAL FOR ABDOMINAL DISCOMFORT. LATER, IN THE HOSPITAL, THE PATIENT HAD A CARDIAC ARREST POSSIBLE BASED ON HYPOKALEMIA FOR WHICH RESUSCITATION WAS PERFORMED. THE PATIENT UNDERWENT IVTM THERAPY POST-CARDIAC ARREST. THERE WERE NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT BEFORE COOLING WITH THE IVTM SYSTEM. AN ICY CATHETER (LOT # 151767) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. CATHETER PLACEMENT WAS SMOOTH AND WAS COMPLETED IN ONE ATTEMPT. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE IVTM THERAPY WAS 37° C. THE COOLING TARGET TEMPERATURE WAS SET AT 34° C, AND THE THERMOGARD CONSOLE WAS SET AT THE MAXIMUM COOLING RATE TO COOL THE PATIENT. ELEVEN HOURS AFTER THE START OF THE TREATMENT, THE THERMOGARD CONSOLE GENERATED AN "AIR TRAP" ALARM. SUBSEQUENTLY, IT WAS NOTED THAT THE AIR TRAP CHAMBER WAS EMPTY 1/3RD EMPTY. NO TRACES OF SALINE WERE OBSERVED ON THE FLOOR, PATIENT'S BED, OR ON THE CONSOLE. THE PATIENT'S BODY TEMPERATURE WAS 34.1° C WHEN THE ISSUE WAS NOTED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT, AND A STANDARD CVC (WITH 5 LUMENS) WAS INSTALLED AND PATIENT COOLING CONTINUED USING AN ALTERNATIVE METHOD. AFTER THE CATHETER WAS REMOVED, IT WAS NOTED THAT A BLOOD CLOT WAS PRESENTED ON THE CATHETER AND A LEAK WAS FOUND IN ONE OF THE CATHETER BALLOONS. AS REPORTED, ASPIRATION OF BLOOD FROM THE IN-LUERED LUMEN WAS PERFORMED. INFUSION OF ABOUT 250 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. APPROXIMATELY 36 HOURS AFTER STARTING THE IVTM TREATMENT, THE PATIENT WAS PRONOUNCED DEAD. AS PER THE CUSTOMER, THE CAUSE OF DEATH WAS DUE TO THE PATIENT'S CO-MORBIDITY, UNRELATED TO THE IVTM SYSTEM AND CATHETER.

    Additional Manufacturer Narrative · 1

    THE ICY CATHETER IN COMPLAINT WAS RETURNED TO ZOLL ON JULY 07, 2021 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED. INFUSION OF AROUND 250 ML AMOUNT LIKELY DID NOT CONTRIBUTE TO PATIENT'S DEATH. IT IS KNOWN THAT ADMINISTRATION OF STERILE SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS. IN AGREEMENT WITH A CUSTOMER, THERE WAS NO PATIENT'S EFFECT ATTRIBUTED ZOLL CATHETER. DEATH WAS PROBABLY RELATED TO THE PATIENT'S CLINICAL CONDITION OF POST-CARDIAC ARREST.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED TO A HOSPITAL FOR ABDOMINAL DISCOMFORT. LATER, IN THE HOSPITAL, THE PATIENT HAD A CARDIAC ARREST POSSIBLE BASED ON HYPOKALEMIA FOR WHICH RESUSCITATION WAS PERFORMED. THE PATIENT UNDERWENT IVTM THERAPY POST-CARDIAC ARREST. THERE WERE NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT BEFORE COOLING WITH THE IVTM SYSTEM. AN ICY CATHETER (LOT # UNKNOWN) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. CATHETER PLACEMENT WAS SMOOTH AND WAS COMPLETED IN ONE ATTEMPT. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE IVTM THERAPY WAS 37¿ C. THE COOLING TARGET TEMPERATURE WAS SET AT 34¿ C, AND THE THERMOGARD CONSOLE WAS SET AT THE MAXIMUM COOLING RATE TO COOL THE PATIENT. ELEVEN HOURS AFTER THE START OF THE TREATMENT, THE THERMOGARD CONSOLE GENERATED AN "AIR TRAP" ALARM. SUBSEQUENTLY, IT WAS NOTED THAT THE AIR TRAP CHAMBER WAS EMPTY 1/3RD EMPTY. NO TRACES OF SALINE WERE OBSERVED ON THE FLOOR, PATIENT'S BED, OR ON THE CONSOLE. THE PATIENT'S BODY TEMPERATURE WAS 34.1¿ C WHEN THE ISSUE WAS NOTED. THE CATHETER WAS THEN REMOVED FROM THE PATIENT, AND A STANDARD CVC (WITH 5 LUMENS) WAS INSTALLED AND PATIENT COOLING CONTINUED USING AN ALTERNATIVE METHOD. AFTER THE CATHETER WAS REMOVED, IT WAS NOTED THAT A BLOOD CLOT WAS PRESENTED ON THE CATHETER AND A LEAK WAS FOUND IN ONE OF THE CATHETER BALLOONS. AS REPORTED, ASPIRATION OF BLOOD FROM THE IN-LUERED LUMEN WAS PERFORMED. INFUSION OF ABOUT 250 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. APPROXIMATELY 36 HOURS AFTER STARTING THE IVTM TREATMENT, THE PATIENT WAS PRONOUNCED DEAD. AS PER THE CUSTOMER, THE CAUSE OF DEATH WAS DUE TO THE PATIENT'S CO-MORBIDITY, UNRELATED TO THE IVTM SYSTEM AND CATHETER. MFR # 3010617000-2021-00671 FOR THE THERMOGARD CONSOLE (S/N UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052315 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 151767 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death