BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 16309392 · Received February 6, 2023

    Report

    Report Number
    3010617000-2023-00120
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 15, 2023
    Report Date
    March 10, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED THE SOLEX 7 CATHETER LOT NUMBER IN SECTION B5 AND D4. THE REPORTED COMPLAINT OF A SUSPECTED SOLEX 7 CATHETER (LOT #171782) LEAK BECAUSE OF A 1000ML SALINE BAG WAS NOTICED EMPTY AND BLOOD-TINGE IN THE SUK WAS CONFIRMED DURING THE FUNCTIONAL PRESSURE LEAK TEST. A PINHOLE LEAK WAS OBSERVED AT THE DISTAL END 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. OBSERVED BLOOD RESIDUES IN THE SERPENTINE BALLOONS AND LUERED TUBINGS. 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 ONE SIMILAR COMPLAINT REPORTED FOR THE SOLEX 7 CATHETER WITH LOT # 171782. CCR (B)(4), REPORTED ON JUL 7, 2022, A PINHOLE LEAK WAS OBSERVED AT THE SERPENTINE BALLOON.

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED, AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    DURING THE MORNING OF IVTM THERAPY, CUSTOMER NOTICED THE 1000ML SALINE BAG WAS EMPTY. THE CUSTOMER PERFORMED LEAK CHECK PER IFU AND SUSPECTED THE SALINE LEAK WAS AT THE ORANGE IN/OUT LUER CONNECTION SITE. THE SALINE BAG WAS REPLACED, AND PATIENT TREATMENT CONTINUED. DURING AT NIGHT, THE CUSTOMER NOTICED BLOOD-TINGE IN THE SUK, AND A BALLOON BREACH WAS SUSPECTED ON THE SOLEX 7 CATHETER (LOT #171782). THE SOLEX 7 CATHETER WAS REPLACED, AND TREATMENT CONTINUED WITH THE SAME THERMOGARD CONSOLE. CATHETER DWELL TIME WAS 48 HRS. THE CATHETER INSERTION WAS SMOOTH INTO THE PATIENT'S LEFT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    DURING THE MORNING OF IVTM THERAPY, CUSTOMER NOTICED THE 1000ML SALINE BAG WAS EMPTY. THE CUSTOMER PERFORMED LEAK CHECK PER IFU AND SUSPECTED THE SALINE LEAK WAS AT THE ORANGE IN/OUT LUER CONNECTION SITE. THE SALINE BAG WAS REPLACED, AND PATIENT TREATMENT CONTINUED. DURING AT NIGHT, THE CUSTOMER NOTICED BLOOD-TINGE IN THE SUK, AND A BALLOON BREACH WAS SUSPECTED ON THE SOLEX 7 CATHETER (LOT #UNKNOWN). THE SOLEX 7 CATHETER WAS REPLACED, AND TREATMENT CONTINUED WITH THE SAME THERMOGARD CONSOLE. CATHETER DWELL TIME WAS 48 HRS. THE CATHETER INSERTION WAS SMOOTH INTO THE PATIENT'S LEFT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100464 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 171782 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown