BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14298723 · Received May 6, 2022

    Report

    Report Number
    3010617000-2022-00515
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 13, 2022
    Report Date
    July 21, 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

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ICY CATHETER SERIAL NUMBER, START-UP KITS SERIAL NUMBERS UPDATED IN B5, ICY CATHETER SERIAL NUMBER UPDATED IN D4 AND ICY CATHETER MANUFATURING DATE IN H4. THE REPORTED COMPLAINT OF A POSSIBLE ICY CATHETER (LOT #170780) LEAK WAS SUSPECTED. WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT DISTAL END OF THE MEDIAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE REPORTED LEAK WAS DUE TO A LATENT DEFECT AT THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. OBSERVED BLOOD RESIDUES IN THE BALLOONS AND LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED, AN ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE ICY CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER UP TO 100 PSI, A BONDING LEAK WAS OBSERVED AT DISTAL END OF 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 COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 170780.

    Description of Event or Problem · 0

    DURING IVTM THERAPY ON MALE POST CARDIAC ARREST PATIENT, THE FACILITY NURSE NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" AND OBSERVED THE 500 ML SALINE BAG WAS EMPTY. SALINE WAS OBSERVED ON THE FLOOR, AND THE START-UP KIT (SUK) (LOT #173881) AIR TRAP WAS PARTIALLY FULL OF SALINE. THE NURSE REPLACED THE SUK ALONG WITH A NEW SALINE BAG AND RESUME TREATMENT WITH THE SAME THERMOGARD CONSOLE. ABOUT 3 HOURS LATER, THE FACILITY NURSE NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" AND OBSERVED THE 500 ML SALINE BAG GOT DECREASED BELOW 100ML. NO SALINE OBSERVED ON THE FLOOR, THERMOGARD CONSOLE, OR ON PATIENT'S BED NEAR THE START-UP KIT (SUK) (LOT #174712) CONNECTION TO THE PATIENT. POSSIBLE ICY CATHETER (LOT #UNKNOWN) LEAK WAS SUSPECTED. THE THERMOGARD CONSOLE WAS PLACED IN STANDBY AND SUK WAS DISCONNECTED FROM PATIENT. THE THERAPY WAS ENDED AT THIS TIME AS PATIENT WAS NORMOTHERMIC. PER REPORTER, THE THERMOGARD CONSOLE IS FUNCTIONING PROPERLY SINCE IT HAD NO ISSUES RESUMING THERAPY AFTER INITIAL SUK ISSUE. ICY CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. PATIENT HAD BEEN IN NORMOTHERMIA PHASE DURING TIME OF OCCURRENCE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. DURING TROUBLESHOOTING OF THE ICY CATHETER BY THE FACILITY NURSE, NO BLOOD NOTED IN THE CATHETER OR SUK TUBING OR SALINE BAG, AND 10ML STERILE SALINE WAS FLUSHED INTO THE "IN" PORT OF CATHETER AND CLEAR SALINE FLOWED WITHOUT DIFFICULTY FROM "OUT" PORT. THE NURSE VACUUMED HELD FOR 10 SECONDS FROM IN PORT OF CATHETER WHILE OCCLUDING OUT PORT OF CATHETER, NO BLOOD RETURN IN CATHETER TUBING OR SYRINGE.

    Description of Event or Problem · 0

    DURING IVTM THERAPY ON MALE POST CARDIAC ARREST PATIENT, THE FACILITY NURSE NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" AND OBSERVED THE 500 ML SALINE BAG WAS EMPTY. SALINE WAS OBSERVED ON THE FLOOR, AND THE START-UP KIT (SUK) (LOT #173881) AIR TRAP WAS PARTIALLY FULL OF SALINE. THE NURSE REPLACED THE SUK ALONG WITH A NEW SALINE BAG AND RESUME TREATMENT WITH THE SAME THERMOGARD CONSOLE. ABOUT 3 HOURS LATER, THE FACILITY NURSE NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" AND OBSERVED THE 500 ML SALINE BAG GOT DECREASED BELOW 100ML. NO SALINE OBSERVED ON THE FLOOR, THERMOGARD CONSOLE, OR ON PATIENT'S BED NEAR THE START-UP KIT (SUK) (LOT #170394) CONNECTION TO THE PATIENT. POSSIBLE ICY CATHETER (LOT #170780) LEAK WAS SUSPECTED. THE THERMOGARD CONSOLE WAS PLACED IN STANDBY AND SUK WAS DISCONNECTED FROM PATIENT. THE THERAPY WAS ENDED AT THIS TIME AS PATIENT WAS NORMOTHERMIC. PER REPORTER, THE THERMOGARD CONSOLE IS FUNCTIONING PROPERLY SINCE IT HAD NO ISSUES RESUMING THERAPY AFTER INITIAL SUK ISSUE. ICY CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN. NO INFORMATION ON HOW EXPERIENCE THE INSERTION PHYSICIAN WITH ZOLL PRODUCT AND UNKNOWN IF THE INSERTION WAS SMOOTH OR DIFFICULT. PATIENT HAD BEEN IN NORMOTHERMIA PHASE DURING TIME OF OCCURRENCE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. DURING TROUBLESHOOTING OF THE ICY CATHETER BY THE FACILITY NURSE, NO BLOOD NOTED IN THE CATHETER OR SUK TUBING OR SALINE BAG, AND 10ML STERILE SALINE WAS FLUSHED INTO THE "IN" PORT OF CATHETER AND CLEAR SALINE FLOWED WITHOUT DIFFICULTY FROM "OUT" PORT. THE NURSE VACUUMED HELD FOR 10 SECONDS FROM IN PORT OF CATHETER WHILE OCCLUDING OUT PORT OF CATHETER, NO BLOOD RETURN IN CATHETER TUBING OR SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413623 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 170780 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown