BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-U

    MDR report key: 15130539 · Received July 29, 2022

    Report

    Report Number
    8010042-2022-01307
    Event Type
    Injury
    Date Received
    July 29, 2022
    Report Date
    July 29, 2022
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K201874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SCREEN SHOTS OR X-RAY PICTURES WERE RECEIVED THEREFORE THE INVESTIGATION CONSISTS ONLY OF AN EVALUATION OF RECEIVED INFORMATION. THERE WAS NO EDI-CATHETER MALFUNCTION THEREFORE ITS RETURN WAS NOT NECESSARY. ACCORDING TO AVAILABLE INFORMATION THE EDI CATHETER WAS IN THE PATIENT FOR 49 HOURS. NO PROBLEMS WERE EXPERIENCE D WITH THE INSERTION OF EDI CATHETER. THE EDI CATHETER WAS AT FIRST INSERTED AT 13 CM BUT IT THE INSERTION LENGTH WAS CHANGED TO 14 CM AFTER 11 HOURS ON THE SAME DAY. THE PATIENT SHOWED ACUTE DECOMPENSATION AND X-RAY WAS DONE. THE XRAY SHOWED THAT THE EDI CATHETER WAS DEEPER THAN IT WAS EARLIER IN THE MORNING, AND IT CONFIRMED A DECUBITUS CONCERNING GASTRIC PERFORATION. THE CONCLUSION BASED ON AVAILABLE INFORMATION IS THAT THE PERFORATION OCCURRED IN THE LAST HOURS BEFORE THE EDI CATHETER WAS REMOVED FROM THE PATIENT. THE TWO X-RAYS SHOWED THAT THE INSERTION LENGTH OF 14 CM WAS NOT THE CAUSE BECAUSE THE FIRST XRAY BEFORE THE DECOMPENSATION SHOWED THAT THE EDI CATHETER WAS NOT DEEP, AND IT HAD BEEN IN PLACE FOR AT LEAST 24 HOURS WHILE THE XRAY AFTER DECOMPENSATION SHOWED A DEEPER POSITION. THE CAUSE OF THE GASTRIC PERFORATION WAS THEREFORE DUE FURTHER MOVEMENT OF THE EDI CATHETER TO A DEEPER LENGTH THAN THE 14 CM. HOW IT WAS MOVED, WHO DID IT OR WHETHER THE SECUREMENT LOOSENED HAS NOT BEEN DETERMINED. H3 OTHER TEXT : DEVICE NOT NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ON VENTILATORY THERAPY ON NIV NAVA (NON-INVASIVE VENTILATORY NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION AS WELL AS A HAVING A REGULAR OROGASTRIC TUBE WAS SHOWING SIGNS OF SEPSIS SO THE PATIENT WAS PREPARED TO INTUBATE. ACCORDING TO THE FACILITY, THE X-RAYS THE NAVA EDI CATHETER LOOKED VERY DEEP BUT IT WAS WITHIN RANGE ON THE PLACEMENT SCREEN. PRIOR TO PULLING THE EDI CATHETER TO INTUBATE, THE PATIENT WAS BAGGED. THE EDI CATHETER WAS PULLED BEFORE PLACING AN ETT. THE X-RAY FOLLOWING INTUBATION SHOWED A LOT OF AIR AROUND THE STOMACH AND CONFIRMED A GASTRIC PERFORATION. THE PERFORATION CLOSED AFTERWARDS. THE FINAL PATIENT INJURY WAS NO INJURY. 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
    2317290 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening