BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 15301079 · Received August 26, 2022

    Report

    Report Number
    3013876692-2022-00057
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 26, 2022
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS AN EVALUATION OF RECEIVED INFORMATION THAT INCLUDED A POSITIONING WINDOW PICTURE OF THE EDI CATHETER, X-RAY PICTURES AND ADDITIONAL INFORMATION PER REQUESTS. THE POSITIONING WINDOW PICTURE SHOWS THAT THE EDI CATHETER WAS HIGH UP WHICH MOST PROBABLY CORRESPONDS TO THE SAID INSERTION LENGTH OF 14 CM AND IT WAS INCORRECT. ACCORDING TO THE INFORMATION FROM THE HOSPITAL IT WAS NOTICED ON THE EDI SIGNAL WAS NOT WELL BUT ACCORDING TO THE HOSPITAL THE POSITIONING WAS WELL. THE EDI CATHETER WAS NOT REMOVED BUT IT WAS PULLED OUT AND REINSERTED FROM THE ORIGINAL 14 CM TO A FINAL LENGTH OF 16 CM. JUDGING BY THE XRAY PICTURES THIS WAS NOT DONE AT ONCE BECAUSE A PICTURE WAS TAKEN AT THE 15 CM LENGTH WHICH SUGGESTS THAT THE ADJUSTMENT TO THE 16 CM LENGTH WAS DONE AFTERWARDS BUT NO X RAY PICTURE AT 16 CM WAS PROVIDED. THE CONCLUSION IN THE MATTER WAS THAT THERE WAS NO EDI CATHETER MALFUNCTION AT ANY TIME BUT A USABILITY ISSUE WHERE THE CORRECT POSITION OF THE EDI CATHETER WAS NOT VERIFIED AT THE START AS RECOMMENDED. THE AFTER ADJUSTMENTS/MOVEMENTS OF THE EDI CATHETER TO ATTAIN GOOD NAVA RESULTED IN THE REPORTED PERFORATION. THE PERFORATION MOST LIKELY OCCURRED DURING THE REINSERTION/ADJUSTMENT/SLIDING OF THE EDI CATHETER TO THE SAID 16 CM OR BEYOND CAUSED BY THE INITIAL INCORRECT LENGTH WHICH WAS TOO HIGH UP THAT PROMPTED PUSHING DOWN TO A LENGTH OF A LEAST 2 CM CAUSED BY THE INITIAL INCORRECT POSITIONING OF THE EDI CATHETER. LENGTH ADJUSTMENT WOULD NORMALLY NOT DIFFER AS MUCH AS 2 CM IN A SINGLE DIRECTION FROM A CALCULATED INSERTION LENGTH AND ONCE THE CORRECT POSITION IS DETERMINED THE EDI CATHETER SHOULD BE SECURED PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT THAT WAS ON VENTILATORY THERAPY WITH THE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION. THE EDI-CATHETER HAD INITIALLY BEEN FIXED AT 14 CM BUT IT WAS NOTICED THAT THE EDI WAVEFORM IN THE POSITIONING WINDOW WAS UNSTABLE. ADJUSTMENTS WERE DONE AND THE EDI CATHETER WAS FIXED AT 16 CM. ON THE SECOND DAY IT WAS OBSERVED THAT THE PATIENT HAD SUFFERED GASTRIC PERFORATION. THE EDI CATHETER WAS REMOVED. THE PERFORATION CLOSED. 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
    481984 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening