BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 19154318 · Received April 22, 2024

    Report

    Report Number
    3010617000-2024-00328
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Report Date
    April 22, 2024
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK FROM THE COOL LINE CATHETER (LOT 190953) WAS CONFIRMED DURING FUNCTIONAL TESTING. A LEAK WAS OBSERVED FROM THE PROXIMAL END OF THE DISTAL BALLOON DUE TO A CIRCUMFERENTIAL TEAR IN THE BALLOON. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. BLOOD RESIDUE WAS OBSERVED IN THE BALLOONS AND LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND LUMEN WERE FLUSHED WITHOUT RESISTANCE. UPON FLUSHING THE IN/OUT LUMEN, A LEAK WAS OBSERVED FROM THE PROXIMAL END OF THE DISTAL BALLOON. DURING FURTHER INSPECTION OF THE CATHETER UNDER A MICROSCOPE, A CIRCUMFERENTIAL TEAR IN THE BALLOON WAS OBSERVED, LOCATED 0.5 CM AWAY FROM PROXIMAL END OF THE DISTAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. PRESSURIZED FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE LEAK DISCOVERED DURING THE IN/OUT LUMEN TEST. 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 NO SIMILAR COMPLAINTS REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 190953.

    Description of Event or Problem · 0

    DUE TO A SALINE LEAK, THE COOL LINE CATHETER (LOT 190953) AND START-UP KIT (SUK) (LOT 192362) WERE REPLACED. IT IS UNCLEAR WHETHER THE SALINE LEAKED FROM THE CATHETER OR FROM SUK. IT IS UNCLEAR WHETHER THE CUSTOMER FOUND THAT THE SALINE WAS LEAKING BECAUSE THE SALINE WAS DECREASING IN THE SALINE BAG, OR WHETHER THEY FOUND THAT THE SALINE WAS LEAKING BECAUSE AN AIR TRAP ALARM SOUNDED. AZM WAS NOTIFIED OF THE INCIDENT WHEN THE DEVICES WERE RETURNED BY THE DISTRIBUTOR. THE DISTRIBUTOR RECEIVED THE DEVICES FROM THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408162 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC CL-2295 190953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown