BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14881218 · Received June 30, 2022

    Report

    Report Number
    3010617000-2022-00702
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    May 30, 2022
    Report Date
    November 13, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "THE CUSTOMER NOTICED THE 500ML SALINE BAG HAD EMPTIED AND BLOOD TINGE IN THE ICY CATHETER (LOT #172706) TUBING" WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER. A LIQUID EMISSION/LEAK WAS OBSERVED FROM THE IN LUER DURING THE LUMEN CROSSTALK TEST. THE PROBABLE ROOT CAUSE IS A WEAKENED WALL BETWEEN THE LUMENS, WHICH WITHSTOOD PRESSURE TESTING DURING MANUFACTURING BUT RESULTED IN A LEAK DURING CLINICAL USE. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND DRIED BLOOD RESIDUE WAS OBSERVED ON THE BALLOONS AND THE LUERED TUBINGS. NO PHYSICAL DAMAGE WAS OBSERVED. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE RETURNED CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. UPON PRESSURIZING THE CATHETER, NO LEAK WAS OBSERVED FROM THE CATHETER BALLOONS. HOWEVER, WATER EMISSION/LEAK WAS OBSERVED FROM IN LUER DURING THE LUMEN CROSSTALK TEST. 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 PREVIOUS HISTORY OF COMPLAINT REPORTED FOR ICY CATHETER WITH LOT #172706. SEEMS THAT AROUND 1000 ML OF STERILE COLD SALINE WAS ENTERED THE PATIENT'S VASCULATURE. 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.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE CUSTOMER HEARD THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM AND NOTICED THE 500ML SALINE BAG HAD EMPTIED. THE CUSTOMER FLUSHED THE LUERS AND NO ISSUE NOTED. TREATMENT CONTINUED BY REPLACING THE SALINE BAG AND START-UP KIT (LOT #175869) ALONG WITH THE SAME THERMOGARD IVTM SYSTEM. IT IS UNKNOWN IF TROUBLESHOOTING WAS PERFORMED PER IFU OR ZOLL CLINICAL FIELD SPECIALIST OR TECHNICAL SUPPORT RECOMMENDATIONS. DURING THE REWARMING PHASE OF THERAPY, THE THERMOGARD IVTM SYSTEM GENERATED AGAIN AN "AIR TRAP WARNING" ALARM AND THE CUSTOMER NOTICED THE 2ND 500ML SALINE BAG HAD EMPTIED. THE CUSTOMER OBSERVED BLOOD TINGE IN THE ICY CATHETER TUBING AND OPTED TO CONTINUE WITH TREATMENT. PER REPORTER, THE ICY CATHETER INSERTION WAS SMOOTH INTO THE PATIENT'S LEFT FEMORAL VEIN AND NO OTHER LINES . UNKNOWN HOW MUCH SALINE INFUSION WAS SUSPECTED. THE THERMOGARD CONSOLE IS FUNCTIONING PROPERLY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE CUSTOMER HEARD THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM AND NOTICED THE 500ML SALINE BAG HAD EMPTIED. THE CUSTOMER FLUSHED THE LUERS AND NO ISSUE NOTED. TREATMENT CONTINUED BY REPLACING THE SALINE BAG AND START-UP KIT (LOT #175869) ALONG WITH THE SAME THERMOGARD IVTM SYSTEM. DURING THE REWARMING PHASE OF THERAPY, THE THERMOGARD IVTM SYSTEM GENERATED AGAIN AN "AIR TRAP WARNING" ALARM AND THE CUSTOMER NOTICED THE 2ND 500ML SALINE BAG HAD EMPTIED. THE CUSTOMER OBSERVED BLOOD TINGE IN THE ICY CATHETER TUBING AND OPTED TO CONTINUE WITH TREATMENT. PER REPORTER, THE ICY CATHETER INSERTION WAS SMOOTH INTO THE PATIENT'S LEFT FEMORAL VEIN AND NO OTHER LINES. UNKNOWN HOW MUCH SALINE INFUSION WAS SUSPECTED. THE THERMOGARD CONSOLE IS FUNCTIONING PROPERLY. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 8/19/2022, THE CUSTOMER ICU MANAGER IS GOING TO BE DOING SOME ADDITIONAL EDUCATION WITH HIS STAFF TO ENSURE THEY KNOW TO BE CALLING THE ZOLL TECH LINE. AS TO WHEN THE ACTUAL TRAINING AND REMINDING HAS OCCURRED, NO PRECISE DATE WAS SCHEDULED. TRAINING WILL BE AN ONGOING REMINDER TO HIS STAFF. PER ADDITIONAL INFORMATION RECEIVED ON 10/13/2022 AND 10/14/2022, RE-TRAINING TO NURSES REGARDING TROUBLESHOOTING PER IFU, CATHETER SPECIFICATIONS, TGXP SETUP, AND TECH LINE AVAILABILITY FOR ADDITIONAL TROUBLESHOOTING CONCERNS ONSITE ON 9/27, 9/28, AND 10/6. PER ZOLL CLINICAL REPRESENTATIVE, EDUCATION WAS DONE ALL VERBALLY WITH HANDS ON TRAINING FOR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549353 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 172706 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown