BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 HEPARIN EU CATHETER

    MDR report key: 16469263 · Received March 2, 2023

    Report

    Report Number
    3010617000-2023-00200
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 25, 2023
    Report Date
    March 31, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE SOLEX CATHETER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED, AND INVESTIGATION HAS BEEN COMPLETED. EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE OF THE NATURE OF THE EVENT AND TREATMENT WAS NEEDED. EVENT ASSESSED AS POSSIBLY RELATED TO THE SOLEX CATHETER DUE TO RELEVANT TIMING. AT THE SAME TIME, ANOTHER CENTRAL VENOUS CATHETER WAS USED IN THE PATIENT EVEN LONGER THAN ZOLL CATHETER PRIOR TO PE EVENT AND ALSO COULD POTENTIALLY CONTRIBUTE TO DEVELOPMENT OF PE. DVT AND SUBSEQUENT PE IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. USUALLY CRITICAL CONDITION MAKE THE PATIENTS PREDISPOSED TO THROMBOGENICITY. DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IS SUCH PATIENT POPULATION. CRITICALLY ILL PATIENTS ARE AT INCREASED RISK OF VTE BECAUSE OF THE PRESENCE OF MULTIPLE PREDISPOSING FACTORS [W. GEERTS, ET AL. VENOUS THROMBOEMBOLISM AND ITS PREVENTION IN CRITICAL CARE. J CRIT CARE, 17 (2002), PP. 95-104]. THE REPORTED EVENT OF PE IS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE SOLEX 7 CATHETER (LOT #173433) WAS RETURNED FOR INVESTIGATION TO ZOLL. NO DEVICE MALFUNCTION WAS OBSERVED DURING THE FUNCTIONAL TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO KINKS OR PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. NOTICED DRIED BLOOD RESIDUES ON THE SERPENTINE BALLOONS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, NO ISSUES WERE OBSERVED. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. NO LEAKS OR DAMAGES WERE FOUND, AND THE CATHETER FUNCTIONED AS INTENDED. EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE OF THE NATURE OF THE EVENT AND TREATMENT WAS NEEDED. EVENT ASSESSED AS POSSIBLY RELATED TO THE SOLEX CATHETER DUE TO RELEVANT TIMING. AT THE SAME TIME, ANOTHER CENTRAL VENOUS CATHETER WAS USED IN THE PATIENT EVEN LONGER THAN ZOLL CATHETER PRIOR TO PE EVENT AND ALSO COULD POTENTIALLY CONTRIBUTE TO DEVELOPMENT OF PE. DVT AND SUBSEQUENT PE IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. USUALLY CRITICAL CONDITION MAKE THE PATIENTS PREDISPOSED TO THROMBOGENICITY. DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IS SUCH PATIENT POPULATION. CRITICALLY ILL PATIENTS ARE AT INCREASED RISK OF VTE BECAUSE OF THE PRESENCE OF MULTIPLE PREDISPOSING FACTORS [W. GEERTS, ET AL. VENOUS THROMBOEMBOLISM AND ITS PREVENTION IN CRITICAL CARE. J CRIT CARE, 17 (2002), PP. 95-104]. THE REPORTED EVENT OF PE IS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    A 37-YEAR-OLD MALE OF WEIGHT AT 90 KG WAS ADMITTED TO THE HOSPITAL WITH AN ANEURYSM. IVTM THERAPY WAS APPLIED FOR FEVER MANAGEMENT. THE PATIENT'S TEMPERATURE AT THE START OF IVTM THERAPY WAS 37.40C. THE INSERTION OF THE SOLEX 7 CATHETER (LOT #173433) WAS SMOOTH IN THE PATIENT'S LEFT SUBCLAVIAN VEIN BY A MODERATELY EXPERIENCED PHYSICIAN. THERE WAS ALSO A RIGHT FEMORAL VEIN CENTRAL VENOUS CATHETER (CVC) ACCESS APPLIED TO THE PATIENT. ON DAY 3, THE PATIENT HAD A DROP IN OXYGEN SATURATION AND CT SCAN WAS INITIATED, WHERE A PULMONARY EMBOLISM (PE) WAS DISCOVERED. THE TARGET TEMPERATURE WAS SET TO 37.00C AT MAX RATE AND IT IS UNKNOWN WHAT TEMPERATURE THE PATIENT HAD WHEN PE OCCURRED. THE SOLEX 7 CATHETER WAS REMOVED FROM THE PATIENT, AND ANTICOAGULATION AND VENTILATION WERE APPLIED. THE PATIENT IS ON FULL HEPARINIZATION FOR PULMONARY EMBOLISM PROPHYLAXIS. AS PER PATIENT MEDICAL HISTORY, THE PATIENT WAS NOT IN A HIGH-RISK CATEGORY FOR DVT. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913501 ZOLL IVTM SOLEX 7 HEPARIN EU CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593AE 173433 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other