BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 16526293 · Received March 10, 2023

    Report

    Report Number
    3010617000-2023-00225
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 10, 2022
    Report Date
    March 10, 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 REPORTED COMPLAINT OF A SUSPECTED SOLEX 7 CATHETER (LOT #181178) LEAK BECAUSE OF A 500ML SALINE BAG WAS NOTICED EMPTY WAS CONFIRMED DURING THE FUNCTIONAL PRESSURE LEAK TEST. A PINHOLE LEAK WAS OBSERVED AT THE MIDDLE OF THE SERPENTINE BALLOON. THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO A LATENT MATERIAL DEFECT. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. DURING FUNCTIONAL TESTING, ALL LUMENS WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT THE MIDDLE OF THE SERPENTINE BALLOON. 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 THE QUATTRO CATHETER WITH LOT # 181178.

    Description of Event or Problem · 0

    AT DAY 3 OF THE IVTM THERAPY, CUSTOMER NOTICED THE 500ML SALINE BAG WAS EMPTY AND THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP" WARNING ALARM. NO FLUID OBSERVED ON THE THERMOGARD CONSOLE OR THE FLOOR. APPROXIMATELY 250ML OF SALINE INFUSED IN THE PATIENT. THE SOLEX 7 CATHETER (LOT #181178) AND SALINE BAG WERE REPLACED, AND TREATMENT CONTINUED WITH THE SAME THERMOGARD IVTM SYSTEM. AFTER 24 HOURS LATER, THE CUSTOMER NOTICED BLOOD-TINGE INSIDE THE SALINE BAG. THE CUSTOMER SUSPECTED THE SECOND SOLEX 7 CATHETER (LOT #181128) WAS LEAKING AND IT WAS REPLACED. PATIENT TREATMENT CONTINUED WITH THE SAME THERMOGARD IVTM SYSTEM. THE INSERTION OF THE SOLEX 7 CATHETERS WERE SMOOTH IN THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN BY AN EXPERIENCED PHYSICIAN. CATHETER DWELL TIME WAS ABOUT 72 HOURS. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: 3010617000-2023-00234 FOR THE SECOND SOLEX 7 CATHETER (LOT #181178).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448981 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593AE 181178 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown