BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 18708303 · Received February 14, 2024

    Report

    Report Number
    3010617000-2024-00136
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 14, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE SOLEX CATHETER (LOT 191654) LEAK WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE DISTAL END OF THE SERPENTINE BALLOON ON THE SOLEX 7 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, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. OBSERVED BLOOD HAD ACCUMULATED/DRIED UP ON THE CATHETER'S SERPENTINE BALLOON AND LUER TUBINGS. A FUNCTIONAL LEAK TEST WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT THE DISTAL END OF THE SERPENTINE BALLOON; THUS, 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 COMPLAINTS REPORTED FOR THE SOLEX CATHETER WITH LOT NUMBER 191654.

    Description of Event or Problem · 0

    DURING THE NORMOTHERMIA PHASE OF TREATMENT, THE CUSTOMER REPORTED THE SOLEX CATHETER (LOT # 191654) HAD BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING AND THE SALINE BAG WAS OBSERVED EMPTY. THERE APPEARS TO BE A LEAK IN THE BALLOONS OF THE CATHETER. THE NURSE STOPPED THE THERAPY AND DISCONNECTED AND CLAMPED THE CATHETER LINES. THE NURSE WAS ADVISED THAT THE REMOVAL OF THE CATHETER WOULD BE RECOMMENDED. THE EXACT DWELL TIME IS UNKNOWN, BUT THE PATIENT HAD BEEN IN THE LAST STAGE OF THE IVTM TREATMENT AT THE TIME OF THE LEAK. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781242 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 191654 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown