BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 15875011 · Received November 28, 2022

    Report

    Report Number
    3010617000-2022-02009
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 6, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075213
    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

    H4: COOL LINE CATHETER LOT #173265 WAS RECEIVED FOR INVESTIGATION. THE REPORTED COMPLAINT THAT "THE CUSTOMER SUSPECTED A COOL LINE CATHETER LEAK DUE TO BLOOD-TINGED WAS NOTICED IMMEDIATELY IN THE TUBING OF THE START-UP KIT AS SOON AS THE CUSTOMER CONNECTED IT TO THE COOL LINE CATHETER (LOT #173265)" WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE PROXIMAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. OBSERVED THE CATHETER SHAFT WAS KINKED AT 3 INCHES AWAY FROM THE CATHETER TIP. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED; HOWEVER, IMPROPER HANDLING OF THE CATHETER CANNOT BE RULED OUT. NOTICED BLOOD RESIDUES IN THE BALLOONS AND LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE PROXIMAL BALLOON, 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 COMPLAINT REPORTED FOR COOL LINE CATHETER WITH LOT NUMBER 173265.

    Description of Event or Problem · 0

    AS REPORTED, BLOOD-TINGED WAS NOTICED IMMEDIATELY IN THE TUBING OF THE START-UP KIT AS SOON AS THE CUSTOMER CONNECTED IT TO THE COOL LINE CATHETER (LOT #174009). THE CUSTOMER SUSPECTED A COOL LINE CATHETER LEAK. THE COOL LINE CATHETER INSERTION SITE WAS AT THE SUBCLAVIAN VEIN, AND THE INSERTING PHYSICIAN IS A FREQUENT USER WITH ZOLL PRODUCT. PER REPORTER, THE CATHETER WAS NOT REPLACED, AND THERE WAS NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED TO THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    AS REPORTED, BLOOD-TINGED WAS NOTICED IMMEDIATELY IN THE TUBING OF THE START-UP KIT AS SOON AS THE CUSTOMER CONNECTED IT TO THE COOL LINE CATHETER (LOT #173265). THE CUSTOMER SUSPECTED A COOL LINE CATHETER LEAK. THE COOL LINE CATHETER INSERTION SITE WAS AT THE SUBCLAVIAN VEIN, AND THE INSERTING PHYSICIAN IS A FREQUENT USER WITH ZOLL PRODUCT. PER REPORTER, THE CATHETER WAS NOT REPLACED, AND THERE WAS NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED TO THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515524 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295AE 173265 00849111075213

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown