BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 15811486 · Received November 16, 2022

    Report

    Report Number
    3010617000-2022-01985
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 15, 2022
    Report Date
    February 1, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 LEAK ON THE ICY CATHETER (LOT #162799) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT PROXIMAL END OF MEDIAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE COULD BE A LATENT DEFECT AT THE BOND. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. DRIED BLOOD RESIDUE WAS OBSERVED IN THE CATHETER BALLOONS AND LUERED TUBINGS. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE 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 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 ARE FOUR SIMILAR COMPLAINTS REPORTED FOR AN ICY CATHETER WITH LOT NUMBER 162799. CATHETER BOND LEAK WAS CONFIRMED: (B)(4), REPORTED ON OCTOBER 01, 2021. (B)(4), REPORTED ON JANUARY 19, 2022 . (B)(4), REPORTED ON JANUARY 19, 2022. (B)(4), REPORTED ON MAY 25, 2022.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, CUSTOMER NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP" WARNING ALARM. LEAK CHECK WAS PERFORMED BUT UNKNOWN IF SALINE WAS NOTICED ON THE FLOOR, PATIENT'S BED OR THERMOGARD CONSOLE. THE CUSTOMER DISCONNECTED THE ICY CATHETER (LOT #162799) AND FLUSHED IT WITH SYRINGE AND OBSERVED NO FLUID RETURNED. A POTENTIAL LEAK ON THE ICY CATHETER WAS SUSPECTED BY THE CUSTOMER AND IT WAS REMOVED. A NEW CATHETER WAS INSERTED TO CONTINUE WITH TREATMENT. IT IS UNKNOWN IF THE "AIR TRAP" WARNING ALARM WAS CLEARED AND IT WAS USED TO CONTINUE WITH TREATMENT. CATHETER DWELL TIME IS UNKNOWN. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR (B)(4) FOR THE THERMOGARD IVTM SYSTEM (SN UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783345 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 162799 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown