BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 17101823 · Received June 9, 2023

    Report

    Report Number
    3010617000-2023-00509
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 2, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075213
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE LEAK AT THE DISTAL AND PROXIMAL INFUSION LUERS OF THE COOL LINE CATHETER (LOT # 173265) WAS CONFIRMED DURING THE VISUAL INSPECTION AND FUNCTIONAL TESTING. BOTH DISTAL AND PROXIMAL INFUSION LUERS ON THE CATHETER WERE CRACKED. THE PROBABLE ROOT CAUSE FOR THE CRACKED LUERS COULD BE DUE TO A LATENT MATERIAL DEFECT OR DUE TO OVER TORQUEING OF THE LUER CONNECTORS. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND THE DISTAL AND PROXIMAL INFUSION LUERS WERE CRACKED. IN ADDITION, UNRELATED TO THE REPORTED COMPLAINT, THE SHAFT OF THE CATHETER WAS CUT 14 CM AWAY FROM THE MANIFOLD BY THE CUSTOMER BEFORE THE ITEM WAS SHIPPED FOR EVALUATION. DURING THE FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO THE SYRINGE, AND UPON APPLYING THE PRESSURE, A LEAK WAS OBSERVED AT THE DISTAL AND PROXIMAL INFUSION LUERS; THUS, CONFIRMING THE REPORTED COMPLAINT. NO FURTHER TESTING OF THE RETURNED CATHETER COULD BE PERFORMED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RECEIVED. 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. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 173265.

    Description of Event or Problem · 0

    THE IVTM THERAPY WAS PERFORMED ON A 68-YEAR-OLD FEMALE PATIENT TO INDUCE HYPOTHERMIA. THE COOL LINE CATHETER (LOT # 173265) WAS INSERTED INTO THE PATIENT'S SUBCLAVIAN VEIN. AT THE START OF IVTM THERAPY, THE PATIENT'S TEMPERATURE WAS 37.6°C. ON (B)(6) 2023, THE NURSE NOTICED A LEAK AT THE DISTAL INFUSION LUERS CONNECTION. PER THE REPORTER, THE DISTAL INFUSION PORT WAS USED TO DELIVER THE NIMOTOP MEDICATION. THE LINE WAS DISCONNECTED, AND THE MEDICATION WAS SWITCHED TO THE PROXIMAL INFUSION LUER. ON (B)(6) 2023, ELEVEN DAYS AFTER THE LEAK INCIDENT, THE SECOND LEAK WAS OBSERVED AT THE PROXIMAL INFUSION LUMEN CONNECTION. THE CATHETER WAS REPLACED. THE THERAPY IS STILL ONGOING. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    A 68 YEARS OLD FEMALE PATIENT UNDERWENT IVTM THERAPY FOR HYPOTHERMIA. THE COOL LINE CATHETER (LOT # 173265) WAS INSERTED INTO THE PATIENT'S SUBCLAVIAN VEIN. AT THE START OF IVTM THERAPY, THE PATIENT'S TEMPERATURE WAS 36.7°C. ON (B)(6) 2023, THE NURSE NOTICED A LEAK AT THE DISTAL INFUSION LUERS CONNECTION. PER THE REPORTER, THE DISTAL INFUSION PORT WAS USED TO DELIVER THE NIMOTOP MEDICATION. THE LINE WAS DISCONNECTED, AND THE MEDICATION WAS SWITCHED TO THE PROXIMAL INFUSION LUER. ON (B)(6) 2023, ELEVEN DAYS AFTER THE LEAK INCIDENT, THE SECOND LEAK WAS OBSERVED AT THE PROXIMAL INFUSION LUMEN CONNECTION. THE CATHETER WAS REPLACED. THE THERAPY IS STILL ONGOING. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237243 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295AE 173265 00849111075213

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female