BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 16931756 · Received May 15, 2023

    Report

    Report Number
    3010617000-2023-00434
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 21, 2023
    Report Date
    October 15, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K081936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION IN D4 (SUSPECTED MEDICAL DEVICE LOT #).

    Additional Manufacturer Narrative · 0

    THE REPORTED PROBLEM OF "A LEAKING SOLEX 7 CATHETER (LOT #181178)" WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED CATHETER. A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE SERPENTINE 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 RIGHT AT THE DISTAL END OF THE MANIFOLD. NOTICED BLOOD RESIDUES IN THE SERPENTINE BALLOON AND LUERED TUBINGS. NO OTHER PHYSICAL DAMAGE WAS OBSERVED. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED; HOWEVER, IMPROPER HANDLING OF THE CATHETER CANNOT BE RULED OUT. FUNCTIONAL TESTING WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE IN/OUT LUMEN TEST, A PINHOLE LEAK WAS OBSERVED AT THE MIDDLE OF SERPENTINE BALLOON, THUS, CONFIRMING THE REPORTED COMPLAINT. PRESSURIZED FUNCTIONAL TESTING NOT NEEDED DUE TO THE PINHOLE LEAK DISCOVERED DURING THE IN/OUT LUMEN TEST. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. ALL CATHETERS ARE 100% INSPECTED FOR LEAKS DURING MANUFACTURING BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE FOLLOWING PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS ONE SIMILAR COMPLAINT REPORTED FOR SOLEX 7 CATHETER WITH LOT #181178. (B)(4), REPORTED ON (B)(6) 2023, A PINHOLE LEAK AT THE MIDDLE OF THE SERPENTINE BALLOON DUE TO A LATENT MATERIAL DEFECT.

    Description of Event or Problem · 0

    DURING IVTM THERAPY ON A 70-YEAR-OLD MALE PATIENT, THE CUSTOMER REPORTED A LEAKING SOLEX 7 CATHETER (LOT #181178). DURING THE REWARMING PHASE TREATMENT, THE CUSTOMER NOTICED AN "AIR TRAP" WARNING ALARM FROM THE THERMOGARD CONSOLE AND OBSERVED BLOOD TINGE ON THE TUBING OF THE START-UP KIT (SUK) SO IT WAS CLEAR THAT A CATHETER LEAK. THE INSERTION WAS SMOOTH INTO THE PATIENT'S RIGHT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN WITH ZOLL PRODUCT. THE CATHETER DWELL TIME WAS 3 DAYS. THE CUSTOMER WAS ABLE TO CLEAR THE "AIR TRAP" WARNING FROM THE THERMOGARD CONSOLE AND IS FUNCTIONING PROPERLY. THE PATIENT HAS ALREADY COMPLETED THE REWARMED PHASE AND DECIDED TO STOP TREATMENT AND THE SOLEX CATHETER WAS REMOVED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651290 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593AE 181178 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male