BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 16526328 · Received March 10, 2023

    Report

    Report Number
    3010617000-2023-00234
    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) HAD A LEAK BECAUSE BLOOD-TINGE WAS NOTICED INSIDE THE SALINE BAG" WAS CONFIRMED DURING THE VISUAL INSPECTION. AS RECEIVED, THE CATHETER SERPENTINE BALLOON WAS COMPLETELY DAMAGED, THE BALLOON LOOPS WERE DETACHED FROM THE PROXIMAL END OF SERPENTINE BALLOON. THE PROBABLE ROOT CAUSE FOR THE DAMAGED BALLOON IS MOST LIKELY ATTRIBUTED TO MISHANDLING AND/OR DURING THE REMOVAL OF THE CATHETER. IN ADDITION, DURING THE VISUAL INSPECTION, THE CATHETER SHAFT WAS KINKED AT THE PROXIMAL END AND AT THE DISTAL END OF THE SERPENTINE BALLOON, UNRELATED TO THE REPORTED COMPLAINT. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED; HOWEVER, IMPROPER HANDLING OF THE CATHETER CANNOT BE RULED OUT. NO OTHER PHYSICAL DAMAGE WAS NOTED. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE EXCEPT FOR THE IN/OUT LUER PORTS. THE IN/OUT LUERED PORTS ARE UNABLE TO FLUSH DUE TO BLOOD CLOGGED, KINKED ON SHAFT AND DUE TO THE DAMAGE OF BALLOONS. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RETURNED. 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 SIMILAR HISTORY OF COMPLAINTS REPORTED FOR THE SOLEX 7 CATHETER WITH LOT NUMBER 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: 3010617000-2023-00225 FOR THE FIRST SOLEX 7 CATHETER (LOT #181178).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515050 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593AE 181178 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown