BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 17021464 · Received May 30, 2023

    Report

    Report Number
    3010617000-2023-00466
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 3, 2023
    Report Date
    June 25, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K081936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOLL INTERPRETED PROBLEM WAS REVISED FOR CORRECTION.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE PROXIMAL INFUSION LUER COULD NO LONGER BE INFUSED, AND WHEN REMOVED, FOUND THAT FLUID PARTIALLY CAME OUT THROUGH THE DISTAL LUER ON THE SOLEX CATHETER (LOT 181178) WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. NO ISSUES OR DISCREPANCIES WERE FOUND. NO DEVICE MALFUNCTION WAS OBSERVED DURING THE TESTING. ALL THE LUMENS WERE FLUSHED WITHOUT RESISTANCE AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL INSPECTION WAS PERFORMED. THE CATHETER RETURNED WITH THE SYRINGE ATTACHED INTO THE PROXIMAL LUER PORT. UPON REMOVING THE SYRINGE, NO ISSUES OR DISCREPANCIES WERE FOUND. OBSERVED BLOOD RESIDUE IN THE PROXIMAL LUER TUBING. NO OTHER PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. FUNCTIONING FLUSHING WAS PERFORMED AND ALL INFUSION LUER PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. NO PROBLEM WAS FOUND DURING FLUSHING THE PROXIMAL INFUSION LUER PORT, THE FLUID WAS EXITED AT THE PROXIMAL INFUSION HOLE. A FUNCTIONAL PRESSURE LEAK TEST WAS PERFORMED. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, AND NO LEAK OR ISSUES WERE OBSERVED. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION, THE CATHETER FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    DURING IVTM THERAPY ON A CARDIAC ARREST MALE PATIENT, AND AFTER 11 HOURS OF TREATMENT, ADMINISTRATION OF NOREPINEPHRINE MEDICATION VIA THE PROXIMAL INFUSION LUER COULD NO LONGER BE INFUSED. WHEN IN THE FURTHER COURSE AN ANTIBIOTIC INFUSION WAS TRIED TO BE GIVEN, THE ANTIBIOTIC RAN INTO THE SURROUNDING SKIN TISSUE AND NOT INTO THE VEIN. THE PATIENT TEMPERATURE WAS AT 36°C AT THE START OF TREATMENT, AND THE TARGET TEMPERATURE AT 33°C WAS ACCOMPLISHED WHEN THE ISSUE WAS NOTED. THE CUSTOMER REMOVED THE SOLEX 7 CATHETER (LOT #181178) AND FOUND THAT FLUID PARTIALLY CAME OUT THROUGH THE DISTAL LUER. THE IVTM TREATMENT WAS DISCONTINUED SINCE PATIENT TARGET TEMPERATURE WAS ACCOMPLISHED. THE SOLEX 7 CATHETER INSERTION WAS SMOOTH INTO THE PATIENT RIGHT INTERNAL JUGULAR. NO ALARMS GENERATED FROM THERMOGARD CONSOLE, AND THE CUSTOMER DID NOT OBSERVE ANY LEAK FLUID ON THERMOGARD CONSOLE, PATIENT BED OR ON THE FLOOR. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    DURING IVTM THERAPY ON A CARDIAC ARREST MALE PATIENT, AND AFTER 11 HOURS OF TREATMENT, ADMINISTRATION OF NOREPINEPHRINE MEDICATION VIA THE PROXIMAL INFUSION LUER COULD NO LONGER BE INFUSED. WHEN IN THE FURTHER COURSE AN ANTIBIOTIC INFUSION WAS TRIED TO BE GIVEN, THE ANTIBIOTIC RAN INTO THE SURROUNDING SKIN TISSUE AND NOT INTO THE VEIN. THE PATIENT TEMPERATURE WAS AT 36°C AT THE START OF TREATMENT, AND THE TARGET TEMPERATURE AT 33°C WAS ACCOMPLISHED WHEN THE ISSUE WAS NOTED. THE CUSTOMER REMOVED THE SOLEX CATHETER (LOT #181178) AND FOUND THAT FLUID PARTIALLY CAME OUT THROUGH THE DISTAL LUER. THE SOLEX 7 CATHETER INSERTION WAS SMOOTH INTO THE PATIENT RIGHT INTERNAL JUGULAR. NO ALARMS GENERATED FROM THERMOGARD CONSOLE, AND THE CUSTOMER DID NOT OBSERVE ANY LEAK FLUID ON THERMOGARD CONSOLE, PATIENT BED OR ON THE FLOOR. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729170 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593AE 181178 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 Male