BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14418149 · Received May 17, 2022

    Report

    Report Number
    3010617000-2022-00497
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075527
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    THE REPORTED COMPLAINT OF A ICY CATHETER (LOT #161453) LEAK WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT PROXIMAL END OF 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 EXAMINATION OF THE RETURNED ICY CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND. 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 PROXIMAL END 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 WERE 2 SIMILAR COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 161453. CCR 59559, REPORTED ON SEPTEMBER 6, 2021 AND CCR 59587, REPORTED ON SEPTEMBER 08, 2021. A BALLOON BOND LEAK WAS NOTED DUE TO A LATENT DEFECT AT THE BOND.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE THERMOGARD IVTM SYSTEM (B)(4) GENERATED AN ALARM AND IT DISPLAYED MID:01 POST WATCHDOG ERROR MESSAGE. THE CUSTOMER NOTED A NEARLY EMPTY 1000 ML SALINE BAG, BLOOD-TINGED IN START-UP KIT (SUK) TUBING, AND NO LEAKED SALINE NOTED AROUND THE PATIENT OR ON THE FLOOR AROUND THE THERMOGARD SYSTEM. AN ICY CATHETER LOT #UNKNOWN BALLOON LEAK WAS SUSPECTED. IT IS UNKNOWN HOW MUCH SALINE INFUSED INTO THE PATIENT'S BODY. PER THE REPORTER, IVTM THERAPY CONTINUED WITHOUT REPLACING THE SALINE BAG AND CATHETER BECAUSE THE PATIENT HAS COMPLETED THE COOLING PHASE AND IS NOW IN THE MAINTENANCE PHASE. ALSO, THE INTENSIVIST DID NOT WANT TO REMOVE THE CATHETER DUE TO THE PATIENT IS FULLY ANTICOAGULATED AND MAYBE AT RISK OF BLEEDING. NO OTHER LINES PRESENT AT THE INSERTION SITE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00499 FOR THE THERMOGARD CONSOLE (B)(4).

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE THERMOGARD IVTM SYSTEM (SN (B)(6) GENERATED AN ALARM AND IT DISPLAYED MID:01 (POST WATCHDOG) ERROR MESSAGE. THE CUSTOMER NOTED A NEARLY EMPTY 1000 ML SALINE BAG, BLOOD-TINGED IN START-UP KIT (SUK) LOT #159800 TUBING, AND NO LEAKED SALINE NOTED AROUND THE PATIENT OR ON THE FLOOR AROUND THE THERMOGARD SYSTEM. AN ICY CATHETER (LOT #161453) BALLOON LEAK WAS SUSPECTED. IT IS UNKNOWN HOW MUCH SALINE INFUSED INTO THE PATIENT'S BODY. PER THE REPORTER, IVTM THERAPY CONTINUED WITHOUT REPLACING THE SALINE BAG AND CATHETER BECAUSE THE PATIENT HAS COMPLETED THE COOLING PHASE AND IS NOW IN THE MAINTENANCE PHASE. ALSO, THE INTENSIVIST DID NOT WANT TO REMOVE THE CATHETER DUE TO THE PATIENT IS FULLY ANTICOAGULATED AND MAYBE AT RISK OF BLEEDING. NO OTHER LINES PRESENT AT THE INSERTION SITE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395836 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893CO 161453 00849111075527

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown