BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 18661026 · Received February 7, 2024

    Report

    Report Number
    3010617000-2024-00159
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    December 20, 2023
    Report Date
    February 7, 2024
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111050043
    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 LUER OF THE ICY CATHETER (LOT 188004) WAS CONFIRMED DURING FUNCTIONAL TESTING. A WATER EMISSION/LEAK WAS OBSERVED FROM THE IN LUER 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. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED AND THE DISTAL INFUSION LUERED TUBING WAS OBSERVED TO BE COMPLETELY CUT OFF BY CUSTOMER (1 INCH AWAY FROM PROXIMAL END OF MANIFOLD). BLOOD RESIDUES WERE OBSERVED ON THE BALLOONS AND LUERED TUBINGS. NO OTHER PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL LUMENS WERE FLUSHED WITHOUT RESISTANCE, EXCEPT THE DISTAL LUER DUE TO THE OBSERVED DAMAGE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE RETURNED 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 IN LUER 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 188004.

    Description of Event or Problem · 0

    ON 12/20/2023, IVTM THERAPY BEGAN FOR THE PATIENT. IMMEDIATELY AFTER STARTING THERAPY, THE SALINE BEGAN LEAKING FROM THE LUER OF THE START-UP KIT (SUK) (LOT 191352). THE CUSTOMER DID NOT TIGHTEN THE LUER TOO MUCH BUT FELT IT DID NOT MESH WELL. THE SUK WAS REPLACED WITH A NEW ONE, BUT THE LUER LEAK ISSUE WAS NOT RESOLVED. UPON FOLLOW UP, THE LEAKING LUER WAS DUE TO THE ICY CATHETER (LOT 188004). SUBSEQUENTLY, THE CATHETER WAS REPLACED WITH A NEW ONE TO CONTINUE THERAPY. THE SAME CONSOLE WAS USED TO CONTINUE THERAPY USING THE SECOND SUK AND CATHETER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180893 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC IC-3893AE 188004 00849111050043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown