BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 18813433 · Received February 29, 2024

    Report

    Report Number
    3010617000-2024-00168
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    January 30, 2024
    Report Date
    April 13, 2024
    Manufacturer
    ZOLL CIRCULATION
    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 ZOLL COOL LINE CATHETER WAS NOT RETURNED TO ZOLL FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK OF THE COOL LINE CATHETER (LOT# 190953) WAS CONFIRMED DURING FUNCTIONAL TESTING. A WATER EMISSION/LEAK WAS OBSERVED FROM THE DISTAL LUER PORT AND AT THE DISTAL END OF THE CATHETER BLUE TIP DURING THE LUMEN CROSSTALK TEST. THE PROBABLE ROOT CAUSE IS A WEAKENED WALL BETWEEN THE LUMENS, WHICH WITHSTOOD PRESSURE TESTING DURING MANUFACTURING BUT RESULTED IN A LEAK DURING CLINICAL USE. A VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL THE INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, NO LEAK WAS OBSERVED FROM THE CATHETER BALLOONS. HOWEVER, A WATER EMISSION/LEAK WAS OBSERVED FROM THE DISTAL LUER PORT AND AT THE DISTAL END OF THE CATHETER BLUE TIP (DISTAL INFUSION LUMEN OPENING HOLE) DURING THE LUMEN CROSSTALK TEST, 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 NO SIMILAR COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 190953. .

    Description of Event or Problem · 0

    ON JANUARY 30, 2024, IVTM THERAPY WITH A COOL LINE CATHETER (LOT# 191450) STARTED. THE CATHETER WAS INSERTED SMOOTHLY ON THE FIRST ATTEMPT INTO THE JUGULAR VEIN. HOWEVER, ON THE FOLLOWING DAY, THE CUSTOMER ENDED TEMPERATURE MANAGEMENT WHEN THE CONSOLE DISPLAYED AN AIR TRAP ALARM AND THE CUSTOMER SUSPECTED A CATHETER LEAK AND THE INFUSION OF THE 200 ML OF SALINE. PER THE REPORTER, THE CATHETER LEAK TEST WAS PERFORMED BY THE PHYSICIAN, AND THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. NO ALTERNATIVE DEVICES OR OTHER TEMPERATURE MANAGEMENT THERAPY WAS UTILIZED AFTER THE THERAPY WAS STOPPED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    ON JANUARY 30, 2024, IVTM THERAPY WITH A COOL LINE CATHETER (LOT# 190953) STARTED. THE CATHETER WAS INSERTED SMOOTHLY ON THE FIRST ATTEMPT INTO THE JUGULAR VEIN. HOWEVER, ON THE FOLLOWING DAY, THE CUSTOMER ENDED TEMPERATURE MANAGEMENT WHEN THE CONSOLE DISPLAYED AN AIR TRAP ALARM AND THE CUSTOMER SUSPECTED A CATHETER LEAK AND THE INFUSION OF THE 200 ML OF SALINE. PER THE REPORTER, THE CATHETER LEAK TEST WAS PERFORMED BY THE PHYSICIAN, AND THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. NO ALTERNATIVE DEVICES OR OTHER TEMPERATURE MANAGEMENT THERAPY WAS UTILIZED AFTER THE THERAPY WAS STOPPED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298278 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 190953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown