BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 11795008 · Received May 7, 2021

    Report

    Report Number
    3010617000-2021-00393
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B5 (DESCRIBE EVENT OR PROBLEM) WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    B5 (DESCRIBE EVENT OR PROBLEM) WAS UPDATED BASED ON THE RECEIVED ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    A PATIENT WITH CHRONIC PULMONARY ASPERGILLOSIS (CPA) WAS ADMITTED FOR IVTM THERAPY, AND THE QUATTRO CATHETER (LOT # 142198) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED. DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, THE THERMOGARD CONSOLE GENERATED AN AIR TRAP ALARM. FOLLOWING THE ALARM, IT WAS NOTED THAT THE 500-ML SALINE BAG WAS EMPTY, AND AIR BUBBLES WERE OBSERVED THROUGHOUT THE START-UP KIT (SUK) TUBING. TINY AIR BUBBLES WERE NOTICED AROUND THE INFLOW AND OUTFLOW LUMENS OF THE SUK. THERE WAS NO BLOOD TINGE IN THE TUBING. THERE WERE NO TRACES OF SALINE OBSERVED ON THE PATIENT'S BED, FLOOR, OR CONSOLE. A CATHETER LEAK AND INFUSION OF ABOUT 400 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THE USER DID NOT REPLACE THE CATHETER AS THE ISSUE WAS NOTED TOWARDS THE END OF THE TREATMENT, AND THE PATIENT'S BODY TEMPERATURE HAD BECOME STABLE. THE CATHETER WAS REMOVED, AND THE THERAPY WAS ENDED. UPON INSPECTION, THE BIOMEDICAL ENGINEER FOUND A LEAK ON THE CATHETER WHEN THE CATHETER WAS SLIGHTLY BENT. THE BIOMED FLUSHED THE CATHETER WITH SALINE AND FOUND A PINHOLE LEAK BETWEEN THE MEDIAL 1 AND PROXIMAL BALLOONS. THE USER IS CONCERNED IF AIR COULD HAVE POSSIBLY ENTERED THE PATIENT'S BLOODSTREAM DUE TO THE PRESENCE OF THE AIR BUBBLES IN THE SUK TUBING. NO DEVICE MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OF AIR EMBOLISM. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    A PATIENT WITH CHRONIC PULMONARY ASPERGILLOSIS (CPA) WAS ADMITTED FOR IVTM THERAPY, AND THE QUATTRO CATHETER (LOT #: 142198) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED. DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, THE THERMOGARD CONSOLE GENERATED AN AIR TRAP ALARM. FOLLOWING THE ALARM, IT WAS NOTED THAT THE 500-ML SALINE BAG WAS EMPTY, AND AIR BUBBLES WERE OBSERVED THROUGHOUT THE START-UP KIT (SUK) TUBING. TINY AIR BUBBLES WERE NOTICED AROUND THE INFLOW AND OUTFLOW LUMENS OF THE SUK. THERE WAS NO BLOOD TINGE IN THE TUBING. THERE WERE NO TRACES OF SALINE OBSERVED ON THE PATIENT'S BED, FLOOR, OR CONSOLE. A CATHETER LEAK AND INFUSION OF ABOUT 400 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THE USER DID NOT REPLACE THE CATHETER AS THE ISSUE WAS NOTED TOWARDS THE END OF THE TREATMENT, AND THE PATIENT'S BODY TEMPERATURE HAD BECOME STABLE. THE CATHETER WAS REMOVED, AND THE THERAPY WAS ENDED. THE HOSPITAL'S BIOMEDICAL ENGINEER INSPECTED THE CATHETER AND NOTED THAT THE CATHETER WAS SLIGHTLY CURVED/BENT. THE BIOMED FLUSHED THE CATHETER WITH SALINE AND FOUND A PINHOLE LEAK BETWEEN THE MEDIAL 1 AND PROXIMAL BALLOONS. THE USER IS CONCERNED IF AIR COULD HAVE POSSIBLY ENTERED THE PATIENT'S BLOODSTREAM DUE TO THE PRESENCE OF THE AIR BUBBLES IN THE SUK TUBING. NO DEVICE MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OF AIR EMBOLISM. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF "THE QUATTRO CATHETER LEAK" WAS CONFIRMED DURING FUNCTIONAL TESTING. THE CUSTOMER REPORTED THAT THE AIR TRAP ALARM WAS TRIGGERED. A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL 1 BALLOON. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD BE A LATENT DEFECT AT THE BOND. THE REPORTED COMPLAINT OF "THE CATHETER WAS NOTED TO BE SLIGHTLY CURVED/BENT" WAS NOT CONFIRMED DURING THE VISUAL INVESTIGATION PERFORMED AT ZOLL. UPON VISUAL INSPECTION OF THE RETURNED CATHETER, NO PHYSICAL DAMAGE WAS FOUND AND NO UNUSUAL CURVE OR BENT WAS NOTED. DRIED BLOOD RESIDUE WAS OBSERVED ON THE CATHETER'S BALLOONS AND ON THE MEDIAL LUERED TUBING. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. 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 BOND LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL 1 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 SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR THE QUATTRO CATHETER WITH LOT NUMBER 142198. BASED ON ZOLL'S MEDICAL SAFETY ASSESSMENT, WE DO NOT KNOW ANY POSSIBLE WAY FOR A SIGNIFICANT VOLUME OF AIR TO ENTER THE PATIENT'S BLOODSTREAM. THIS IS BECAUSE THE AIR TRAP AND LEVEL SENSOR ARE UPSTREAM OF THE CATHETER, AND SINCE THE TUBING IS UNDER POSITIVE PRESSURE, ANY BREACH WILL PUSH AIR OUT OF THE SYSTEM RATHER THAN SUCKING AIR IN. THE CUSTOMER CONFIRMED THAT THE PATIENT DID NOT HAVE ANY SYMPTOMS RELATED TO A POTENTIAL AIR EMBOLISM. 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, THERE WAS NO PATIENT'S EFFECT ATTRIBUTED TO THE ZOLL CATHETER.

    Description of Event or Problem · 1

    A PATIENT WITH CHRONIC PULMONARY ASPERGILLOSIS (CPA) WAS ADMITTED FOR IVTM THERAPY, AND THE QUATTRO CATHETER (LOT # 142198) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED. DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, THE THERMOGARD CONSOLE GENERATED AN AIR TRAP ALARM. FOLLOWING THE ALARM, IT WAS NOTED THAT THE 500-ML SALINE BAG WAS EMPTY, AND AIR BUBBLES WERE OBSERVED THROUGHOUT THE START-UP KIT (SUK) TUBING. TINY AIR BUBBLES WERE NOTICED AROUND THE INFLOW AND OUTFLOW LUMENS OF THE SUK. THERE WAS NO BLOOD TINGE IN THE TUBING. THERE WERE NO TRACES OF SALINE OBSERVED ON THE PATIENT'S BED, FLOOR, OR CONSOLE. A CATHETER LEAK AND INFUSION OF ABOUT 400 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THE USER DID NOT REPLACE THE CATHETER AS THE ISSUE WAS NOTED TOWARDS THE END OF THE TREATMENT, AND THE PATIENT'S BODY TEMPERATURE HAD BECOME STABLE. THE CATHETER WAS REMOVED, AND THE THERAPY WAS ENDED. THE HOSPITAL'S BIOMEDICAL ENGINEER INSPECTED THE CATHETER AND NOTED THAT THE CATHETER WAS SLIGHTLY CURVED/BENT. THE BIOMED FLUSHED THE CATHETER WITH SALINE AND FOUND A PINHOLE LEAK BETWEEN THE MEDIAL 1 AND PROXIMAL BALLOONS. THE USER IS CONCERNED IF AIR COULD HAVE POSSIBLY ENTERED THE PATIENT'S BLOODSTREAM DUE TO THE PRESENCE OF THE AIR BUBBLES IN THE SUK TUBING. NO DEVICE MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687152 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0783-03 142198

    Patients

    Seq Age Sex Outcome Treatment
    1