BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-U

    MDR report key: 15690412 · Received October 28, 2022

    Report

    Report Number
    3013876692-2022-00068
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    October 6, 2022
    Report Date
    February 15, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K201874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EDI CATHETER WAS RETURNED BUT LOGS FROM THE VENTILATOR WITH WHICH IT WAS BEING USED WERE NOT RECEIVED, AND NEITHER WERE ANY POSITION WINDOW¿S SCREEN SHOTS RECEIVED. THE INVESTIGATION THEREFORE CONSISTS OF AN EVALUATION OF AVAILABLE INFORMATION, VISUAL OBSERVATION OF THE RETURNED EDI CATHETER, LEAKAGE TEST TO SEE IF THE THERE WAS ANY DAMAGE/HOLE ON THE EDI CATHETER AND CHECKING WHETHER ALL THE ELECTRODES WERE INTACT BY RESISTANCE MEASURING. NO PROBLEM FOUND WITH THE RETURNED EDI CATHETER. THERE WAS NO VISIBLE DAMAGE ON THE EDI CATHETER, NO LEAKAGE WAS DETECTED, AND ALL ELECTRODES WERE INTACT IMPLYING THAT THEY COULD PICK UP THE EDI SIGNALS. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER THE INSERTION PROCEDURE AND THE INSERTION LENGTH SEEM TO BE CORRECT. BUT NO EDI SIGNALS WERE RECEIVED AFTER INSERTION OF THE REPLACEMENT EDI CATHETER DESPITE INSERTING IT AT THE SAME LENGTH AS THE PREVIOUS ONE AND VERIFYING ITS POSITION WITH THE LITMUS PAPER RESULT. THE LITMUS PAPER RESULT INDICATES CORRECT PLACEMENT BASED ON THE GASTRIC PH BUT IT DOES NOT CONFIRM THAT THE EDI CATHETER¿S ELECTRODES WERE CORRECTLY PLACED AND PICKING UP THE EDI SIGNALS. THE DRAWING OF AIR AFTERWARDS INDICATES THAT THE NUTRITION/EVACUATION HOLES WERE IN AIR POCKET BASED ON OUR FINDING THAT THERE WERE NO OTHER HOLES BUT THEIR POSITION AT THE TIME CANNOT BE DETERMINED. THE CONCLUSION IN THE MATTER IS THAT NO PROBLEM HAS BEEN FOUND WITH THE RETURNED EDI CATHETER WHICH IMPLIES THAT IT SHOULD HAVE WORKED WITHOUT ANY ISSUES AND SHOULD HAVE PICKED UP THE EDI SIGNALS. WHILE THE DESCRIBED INSERTION PROCEDURE, THE INSERTION LENGTH, AND POSITION DETERMINATION OF THE EDI CATHETER IN THE STOMACH BY THE LITMUS PAPER RESULT OF THE GASTRIC PH WERE CORRECT BUT THIS DOES NOT CONFIRM THAT THE EDI CATHETER¿S ELECTRODES WERE CORRECTLY PLACED TO PICK UP THE EDI SIGNALS. GOOD POSITIONING FOR NAVA FUNCTIONING IS DETERMINED BY THE POSITION OF THE P WAVE AND QRS COMPLEX ON THE FOUR ECG LEADS IN THE POSITIONING WINDOW. NO POSITIONING WINDOW SHOTS WERE PROVIDED. THE CAUSE OF THE REPORTED ABSENCE OF EDI SIGNALS WAS MOST PROBABLY THE INCORRECT POSITION OF THE EDI CATHETER¿S ELECTRODES. THE CAUSE OF THE REPORTED EXTRACTED AIR HAS NOT BEEN DETERMINED OR EXPLAINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VENTILATORY NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) VENTILATION, A CHANGE OF THE EDI CATHETER USED FOR NAVA ON A PATIENT WAS DONE AND AFTER THE CHANGE IT BECAME DIFFICULT TO GET A SIGNAL EVEN THOUGH THE EDI CATHETER WAS THE SAME LENGTH AS THE PREVIOUS ONE. THE EDI CATHETER'S POSITION WAS CHECKED WITH LITMUS PAPER. THE PATIENT BECAME MORE SWAYED IN SATURATION AND PULSE. WHEN DRAWING WITH A SYRINGE FROM THE EDI CATHETER, AN INCREDIBLE AMOUNT OF AIR WAS DRAWN. ANOTHER NEW EDI CATHETER WAS INSERTED INTO THE OTHER NOSTRIL AND IT WORKED IMMEDIATELY. THE FINAL PATIENT OUTCOME WAS NO HARM. 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
    2795902 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening