BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDI CATHETER

    MDR report key: 17610947 · Received August 24, 2023

    Report

    Report Number
    8010042-2023-01644
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    August 13, 2023
    Report Date
    August 24, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS REPORTEDLY NO PROBLEMS INSERTING THE EDI CATHETER, WHICH WAS USED FOR MONITORING AND VENTILATION IN NAVA MODE. THE EDI CATHETER WAS NOT USED FOR FEEDING, MEDICATION OR ASPIRATION WHERE A DIFFERENT NASOGASTRIC TUBE WAS USED INSTEAD. THE NAVA VENTILATION WORKED NORMALLY WITH CLEAN EDI WAVEFORMS UNTIL THE LAST DAY PRIOR WITHDRAWAL WHEN NOISE WAS NOTED ON THE EDI WAVEFORM. THE EDI CATHETER WAS RETURNED FOR INVESTIGATION. THE DISTAL TIP MEASURING 9 CM WAS BROKEN OFF AND DISCOLORED. THERE WAS NO VISIBLE SWELLING. THE ELECTRODES WERE MISSING. DUE TO THE DAMAGES NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED. ACCORDING TO RECEIVED INFORMATION, THE EDI CATHETER WAS USED FOR 13 DAYS, WHICH EXCEEDED THE RECOMMENDED DURATION OF USAGE OF 5 DAYS AS OUTLINED IN THE USER¿S MANUAL. A CHECK OF THE MATERIAL PARAMETERS FOR THE SUBJECTED EDI CATHETER SHOWED THAT ALL PARAMETERS WERE WITHIN THE SPECIFIED LIMITS DURING MANUFACTURING. THE PRODUCT MET THE FINAL RELEASE CRITERIA. THERE WERE NO NON-CONFORMITIES IDENTIFIED WITH THE BATCH. THERE ARE NO INDICATIONS OF AN EDI CATHETER MALFUNCTION. THE CAUSE OF BREAKAGE OF THE EDI CATHETER WHEN IT WAS EXTRACTED HAS NOT BEEN CONCLUSIVELY DETERMINED BUT A COMBINATION OF EFFECTS FROM THE SURROUNDING CHEMICAL AND BIOLOGICAL ENVIRONMENT IN THE STOMACH AND THE EXTENDED DURATION OF USE COULD HAVE CAUSED OR CONTRIBUTED TO THE BREAKAGE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, WHEN THE EDI CATHETER WAS REMOVED FROM THE PATIENT, IT BROKE LEAVING THE TIP IN THE STOMACH. AN ENDOSCOPY WAS NECESSARY TO REMOVE THE RESIDUAL TIP. THE FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306775 EDI CATHETER GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB ENFIT 12FR/125 CM 3000231967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening