BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 15161599 · Received August 3, 2022

    Report

    Report Number
    3010617000-2022-00975
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 7, 2022
    Report Date
    September 21, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE BALLOON ON THE SOLEX 7 CATHETER (LOT #171782) HAS A LEAK WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT PROXIMAL END OF THE SERPENTINE BALLOON DURING THE DURING IN/OUT LUMEN FLUSHING TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED SOLEX CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND. OBSERVED BLOOD HAD ACCUMULATED / DRIED UP ON THE SOLEX CATHETER'S SERPENTINE BALLOON AND LUERED TUBING. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE, EXCEPT IN/OUT LUER PORTS DUE TO BLOOD CLOGGED. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE SOLEX CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON FLUSHING THE IN/OUT LUMENS, A PINHOLE LEAK WAS OBSERVED AT PROXIMAL END OF SERPENTINE BALLOON (SECOND LOOP FROM PROXIMAL END); 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 COMPLAINT REPORTED FOR SOLEX 7 CATHETER WITH LOT NUMBER 171782.

    Additional Manufacturer Narrative · 0

    CORRECTION B5.

    Description of Event or Problem · 0

    DURING IVTM THERAPY FOR NORMOTHERMIA TREATMENT, THE CUSTOMER NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM AND THE 1L SALINE BAG WAS HANGING SIDEWAYS ON THE BACK HANDLE OF THE THERMOGARD CONSOLE. THE CUSTOMER REPLACED THE 1L SALINE BAG WITH 500ML SALINE BAG. SHORTLY AFTER, THE CUSTOMER OBSERVED BLOOD-TINGE BEGAN TO CIRCULATE IN THE START-UP KIT (SUK) AND STOPPED TREATMENT AND PERFORMED THE LEAK CHECK. PER REPORTER, 500ML LIKELY WAS INFUSED INTO THE PATIENT FROM THE THE 1L SALINE BAG AND 50ML FROM THE 500ML SALINE BAG. THE CUSTOMER CONFIRMED THAT BLOOD RETURNED WHEN THE SOLEX CATHETER (LOT #171782) WAS ASPIRATED WITH THE SLIP TIP SYRINGE. THE SOLEX 7 CATHETER WAS REMOVED AND THE CUSTOMER INFUSED 20ML FLUID INTO THE SOLEX CATHETER'S ORANGE PORT AND CONFIRMED OBVIOUS LEAK ON THE BALLOON. THE SOLEX CATHETER WAS INSERTED INTO THE PATIENT'S LEFT SUBCLAVIANL VEIN. NO OTHER LINES REPORTED IN THE UPPER BODY THAT COULD HAVE MADE CONTACT WITH THE CATHETER. THE SOLEX 7 CATHETER DWELL TIME WAS 4 DAYS. ANOTHER TEMPERATURE MANAGEMENT WAS USED TO CONTINUE TREATMENT. THE THERMOGARD IVTM SYSTEM IS FUNCTIONING PROPERLY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    DURING IVTM THERAPY FOR NORMOTHERMIA TREATMENT, THE CUSTOMER NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM. THE CUSTOMER NOTICED THE 1L SALINE BAG WAS HANGING SIDEWAYS ON THE BACK HANDLE OF THE THERMOGARD CONSOLE AND KNEW IT WAS SUPPOSED TO BE A 500ML SALINE BAG WHEN USING THE THERMOGARD IVTM SYSTEM. THEN, THE CUSTOMER REPLACED THE 1L SALINE BAG TO 500ML SALINE BAG. THE CUSTOMER DO REGULARLY RECEIVES REFRESHER EDUCATION ON HOW TO PERFORMED LEAK CHECK. SHORTLY AFTER, THE CUSTOMER OBSERVED BLOOD-TINGE BEGAN TO CIRCULATE IN THE START-UP KIT (SUK) AND STOPPED TREATMENT AND PERFORMED THE LEAK CHECK. PER REPORTER, 500ML LIKELY WAS INFUSED INTO THE PATIENT FROM THE 1L SALINE BAG AND 50ML FROM THE 500ML SALINE BAG. THE CUSTOMER CONFIRMED THAT BLOOD RETURNED WHEN THE SOLEX CATHETER (LOT #171782) WAS ASPIRATED WITH THE SLIP TIP SYRINGE. THE SOLEX 7 CATHETER WAS REMOVED AND THE CUSTOMER INFUSED 20ML FLUID INTO THE SOLEX CATHETER'S ORANGE PORT AND CONFIRMED OBVIOUS LEAK ON THE BALLOON. THE SOLEX CATHETER WAS INSERTED INTO THE PATIENT'S LEFT SUBCLAVIAN VEIN. NO OTHER LINES REPORTED IN THE UPPER BODY THAT COULD HAVE CONTACT WITH THE CATHETER. THE SOLEX 7 CATHETER DWELL TIME WAS 4 DAYS. ANOTHER TEMPERATURE MANAGEMENT WAS USED TO CONTINUE TREATMENT. THE THERMOGARD IVTM SYSTEM IS FUNCTIONING PROPERLY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870390 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 171782 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown