BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFIT EDI CATHETER

    MDR report key: 14495770 · Received May 25, 2022

    Report

    Report Number
    8010042-2022-00906
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 25, 2022
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EDI CATHETER WAS RETURNED FOR INVESTIGATION. VISUAL ANALYSIS FOUND NO ANOMALIES, THE EDI CATHETER WAS COMPLETE AND HAD NO DAMAGES. THE THREE FEEDING HOLES WAS FOUND CLOGGED. WHAT TYPE OF NUTRITION THAT WAS ADMINISTERED WAS NOT STATED. A SYRINGE WITH WATER OR OTHER LIQUID WAS CONNECTED TO THE FEEDING LUMEN UPON RETURN. IT WAS NOT POSSIBLE TO PUMP THE LIQUID INTO THE EDI CATHETER. THE REPORTED EVENT OF A CLOGGED EDI CATHETER WAS CONFIRMED. AS STATED IN THE USER MANUAL, THE FEEDING LUMEN OF THE EDI CATHETER MUST BE FLUSHED WITH WATER AFTER NUTRITION AND MEDICATION TO PREVENT CLOGGING. IF THIS WAS PERFORMED IS UNKNOWN. THE INABILITY TO PROVIDE NUTRITION VIA THE NASO-GASTROENTERIC ROUTE OF THE EDI CATHETER WILL NOT AFFECT THE NAVA FUNCTIONALITY TO TRANSFER ELECTRICAL ACTIVITY (EDI SIGNALS) TO THE VENTILATOR SYSTEM. THE REPORTED PATIENT DESATURATION WAS ACCORDING TO THE USER FACILITY A CONSEQUENCE OF THE TROUBLESHOOTING PROCEDURE TO REMOVE THE CLOGGING FROM THE EDI CATHETER. THE ROOT CAUSE OF THE OCCLUDED FEEDING LUMEN COULD NOT BE ESTABLISHED BUT THERE ARE NO INDICATIONS THAT AN EDI CATHETER MALFUNCTION IN ANY WAY CAUSED OR CONTRIBUTED TO THE PATIENT DESATURATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EDI CATHETER BECAME CLOGGED. DURING TROUBLESHOOTING PROCEDURE TO REMOVE THE CLOGGING, THE PATIENT DESATURATED TO UNKNOWN LEVEL. THE EDI CATHETER¿S CLOGGING WILL NOT AFFECT NAVA FUNCTION BUT ASPIRATION AND FEEDING. THE FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114875 ENFIT EDI CATHETER GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6FR/50 CM 3000198343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening