BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDI CATHETER ENFIT 8FR/100 CM, 5PCS

    MDR report key: 20439155 · Received October 14, 2024

    Report

    Report Number
    8010042-2024-0001666
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 14, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710004644
    PMA / PMN Number
    K153688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE INVOLVES AN EDI CATHETER USED DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) VENTILATION, A MODE THAT PROVIDES RESPIRATORY SUPPORT BASED ON THE ELECTRICAL ACTIVITY OF THE DIAPHRAGM (EDI). NAVA SYNCHRONIZES ASSISTANCE WITH THE PATIENT'S BREATHING EFFORTS AND REQUIRES AN ACTIVE RESPIRATORY DRIVE. THE EDI CATHETER, A SINGLE-USE NASOGASTRIC (NG) FEEDING TUBE, IS EQUIPPED WITH MEASURING ELECTRODES POSITIONED IN THE ESOPHAGUS TO MONITOR DIAPHRAGM ACTIVITY ACROSS ALL MODES, INCLUDING STANDBY. IT WAS REPORTED THAT THE INVASIVE PART OF THE EDI CATHETER DEVELOPED A LEAKAGE, CAUSING NUTRITION TO LEAK FROM THE PATIENT¿S NOSE. THE EDI CATHETER WAS REPLACED, AND NO FURTHER COMPLICATIONS OCCURRED. UPON RECEIVING THE EDI CATHETER FOR INVESTIGATION, A VISUAL INSPECTION REVEALED NO EXTERNAL ANOMALIES, AND ITS FULL LENGTH WAS INTACT. HOWEVER, A LEAKAGE TEST USING A SYRINGE FILLED WITH WATER CONFIRMED A LEAK AT THE NINTH ELECTRODE. THE LOT NUMBER OF THE AFFECTED EDI CATHETER WAS UNKNOWN, PREVENTING A DEVICE HISTORY RECORD REVIEW. DURING MANUFACTURING, LEAKAGE TESTS ARE CONDUCTED BEFORE THE FEEDING HOLES ARE PUNCHED, AND A FINAL VISUAL INSPECTION IS PERFORMED. ANY HOLES OR DAMAGE SHOULD HAVE BEEN DETECTED AT THAT STAGE. BASED ON THE AVAILABLE INFORMATION, NO MATERIAL DEFICIENCY WAS IDENTIFIED. THE EDI CATHETER APPEARS TO HAVE SUSTAINED DAMAGE, BUT THE CAUSE REMAINS UNKNOWN. THE EXACT ROOT CAUSE OF THE HOLE IN THE EDI CATHETER¿S INSULATION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    NO LOT # RECEIVED, THEREFORE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A LEAKAGE IN THE INVASIVE PART OF THE EDI CATHETER AND NUTRITION CAME OUT OF THE PATIENT'S NOSE. THERE WAS NO PATIENT HARM. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872484 EDI CATHETER ENFIT 8FR/100 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6883901 17325710004644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown