BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDI CATHETER ENFIT 8FR/50 CM, 5PCS

    MDR report key: 20210623 · Received September 13, 2024

    Report

    Report Number
    8010042-2024-01503
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 13, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710004637
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REQUEST FOR AN INVESTIGATION OF THE SUBJECTED VENTILATOR. INVESTIGATION IS BASED ON THE PROVIDED CLINICAL DATA AND THE REVIEW OF THE VENTILATOR LOGS. THE "INSERT CATHETER SLIGHTLY" MESSAGE INDICATES THAT THE EDI CATHETER MAY HAVE BEEN INITIALLY POSITIONED TOO SHALLOW IN THE PATIENT¿S ESOPHAGUS. THE DECISION TO ADVANCE THE EDI CATHETER BY 1 CM COULD HAVE LED TO AN OVER-ADVANCEMENT, WHICH CAUSED THE EDI CATHETER TO ENTER THE STOMACH. THE "BOUNCING" PURPLE SIGNAL OBSERVED ON THE EDI SCREEN IS A COMMON INDICATION THAT THE EDI CATHETER MAY NOT HAVE BEEN PROPERLY POSITIONED, AS THE SIGNAL FLUCTUATES WHEN THE EDI CATHETER IS EITHER TOO SHALLOW OR TOO DEEP. THE OBSERVED TACHYPNEA AND ELEVATED EDI PEAKS AFTER EDI CATHETER ADVANCEMENT MAY HAVE BEEN A CONSEQUENCE OF OVER-VENTILATION DUE TO INCORRECT EDI CATHETER PLACEMENT. THE OVER-VENTILATION LIKELY RESULTED IN THE LOW CO2 (14.7 MMOL/L), WHICH TRIGGERED THE DECISION TO SWITCH TO THE NEONATAL RESUSCITATOR AND EXTUBATE THE PATIENT. THIS IS CONSISTENT WITH THE PATIENT¿S BLOOD GAS RESULT SHOWING HYPOVENTILATION DUE TO THE EDI CATHETER¿S IMPROPER POSITIONING, POTENTIALLY LEADING TO HYPERINFLATION OF THE LUNGS. THE DRAMATIC INCREASE IN THE EDI PEAKS FOLLOWING EDI CATHETER ADVANCEMENT SUGGESTS THAT THE EDI CATHETER POSITION WAS TOO DEEP, WHICH CAN CAUSE THE VENTILATOR TO OVERESTIMATE THE RESPIRATORY EFFORT, LEADING TO AN INACCURATE ASSESSMENT OF THE PATIENT¿S RESPIRATORY STATUS. ONCE THE EDI CATHETER WAS REPOSITIONED CORRECTLY, THE EDI PEAKS RETURNED TO LOWER, NORMAL VALUES, CONFIRMING THAT THE DEEP EDI CATHETER POSITION WAS AFFECTING THE SIGNAL QUALITY AND CONTRIBUTING TO THE TACHYPNEA. THE INVESTIGATION OF THE VENTILATOR LOGS DID NOT SHOW ANY DEVICE OR EDI CATHETER ERRORS. THE ISSUE WAS LIKELY RELATED TO THE EDI CATHETER¿S POSITION AND HOW THAT INFLUENCED THE MEASUREMENT OF RESPIRATORY EFFORT. THE VENTILATOR ITSELF FUNCTIONED AS INTENDED, AND THERE WERE NO MALFUNCTIONS OR ERRORS ASSOCIATED WITH THE DEVICE. THE MOST LIKELY ROOT CAUSE OF THE EVENT WAS INCORRECT EDI CATHETER POSITIONING, SPECIFICALLY AN OVER-ADVANCEMENT INTO THE STOMACH. THIS CAUSED INACCURATE EDI PEAK MEASUREMENTS, WHICH IN TURN CONTRIBUTED TO THE OVER-VENTILATION AND THE OBSERVED LOW CO2 LEVELS. THE PATIENT DID NOT EXPERIENCE HARM AS A RESULT OF THIS EVENT, AND THE SITUATION WAS RESOLVED BY REPOSITIONING THE EDI CATHETER AND EXTUBATING THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) VENTILATION, THE PATIENT BECAME TACHYPNEIC. THE EDI CATHETER POSITION WAS CHANGED. AFTER ADVANCEMENT, THE EDI PEAKS INCREASED DRAMATICALLY BUT THE PATIENT CONTINUED TO REMAIN TACHYPNEIC. THE DECISION WAS MADE TO EXTUBATE THE PATIENT TO ROOM AIR AS THE CO2 LEVEL WAS LOW. THE EDI CATHETER WAS REPOSITIONED FOLLOWING EXTUBATION AND PROPER POSITIONING WAS ESTABLISHED. THE EDI PEAKS RETURNED TO LOWER VALUES. THE EDI CATHETER WAS FINALLY REMOVED AND THE PATIENT REMAINS ON HIGH FLOW NASAL CANNULA IN ROOM AIR. THERE WAS NO PATIENT 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
    1101098 EDI CATHETER ENFIT 8FR/50 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6883900 17325710004637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening