BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-N

    MDR report key: 16654947 · Received March 31, 2023

    Report

    Report Number
    3013876692-2023-00014
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    March 17, 2023
    Report Date
    May 16, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    PMA / PMN Number
    K201874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS AN EVALUATION OF ADDITIONAL INFORMATION RECEIVED PER REQUEST. NO PRODUCT OR VENTILATOR LOGS WERE PROVIDED FOR INVESTIGATION. ACCORDING TO THE INFORMATION FROM THE HEALTHCARE FACILITY THERE WAS NO PARTICULAR DIFFICULTY TO INTRODUCE AND POSITION THE EDI CATHETER IN PLACE. THE PATIENT¿S CONDITION DETERIORATED DIRECTLY AFTER THE PLACEMENT OF THE EDI CATHETER (MODERATE BRADYCARDIA (100 B/MIN), DESATURATION <50% FOR A MAXIMUM OF 1 MIN). THE GASTRIC BLEEDING WAS OBSTRUCTING THE AIRWAY. NO FURTHER ATTEMPTS WAS MADE WITH NAVA VENTILATION. THE PATIENT WAS INTUBATED AND VENTILATION WAS CHANGED TO HFOV (HIGH FREQUENCY OSCILLATORY VENTILATION). AN X-RAY CHECK WAS PERFORMED DIRECTLY AFTER THE INCIDENT, WHICH EXCLUDED GASTRIC PERFORATION. IT IS UNKNOWN WHERE EXACTLY THE BLEEDING ORIGINATED FROM. FINAL PATIENT OUTCOME WAS NO HARM. THE IMPACT WAS AN EMERGENCY INTUBATION AND PROLONGED INTUBATION. PLACEMENT OF THE EDI CATHETER IS PERFORMED ACCORDING TO NORMAL HOSPITAL ROUTINES FOR FEEDING TUBES. HOWEVER, IN ORDER TO FIND THE EDI SIGNAL (DIAPHRAGM ACTIVITY) THE CATHETER MAY NEED TO BE RE-POSITIONED WITH THE HELP OF GUIDANCE ON THE VENTILATOR¿S SCREEN. IF THE EDI CATHETER IS INCORRECTLY POSITIONED, THE EDI SIGNAL WOULD BE WEAK OR ABSENT. THIS IS VISIBLE ON THE USER INTERFACE OF THE SERVO VENTILATOR. WARNINGS AND ALARMS INDICATES IF THE EDI SIGNAL IS NOT SYNCHRONIZED WITH PRESSURE AND FLOW. THERE IS ADEQUATE INFORMATION IN THE USER¿S MANUAL FOR CALCULATING OF THE INSERTION LENGTH AND CORRECT POSITIONING OF THE EDI CATHETER. THERE IS ALSO A CALCULATION TOOL IN THE VENTILATOR TO SUGGEST THE CORRECT EDI CATHETER FOR THE PATIENT AND THE INSERTION LENGTH. NO INFORMATION HAS BEEN PROVIDED OF HOW AND IF ANY OF THESE WERE UTILIZED BY THE USER. IN ORDER NOT TO PERFORATE TISSUE, THE EDI CATHETER IS DESIGNED WITH A CATHETER STIFFNESS AS A PROVEN NASOGASTRIC TUBE. THE EDI CATHETER ALSO HAS A ROUNDED TIP AND IS COVERED WITH A HYDROPHILIC COATING TO REDUCE FRICTION WHEN INSERTED INTO THE PATIENT. THE CONCLUSION IS THAT THERE WAS NO EDI CATHETER MALFUNCTION OR INADEQUATE LABELING/INSERTION/POSITIONING INFORMATION. THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. H3 OTHER TEXT: 4117.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR START OF VENTILATION IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, THERE WAS A GASTRIC PERFORATION WHEN THE NASOGASTRIC EDI CATHETER WAS POSITIONED IN THE STOMACH. THE PATIENT¿S FINAL OUTCOME IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265260 SERVO-N GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB SERVO-N

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Male Life Threatening