BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDI CATHETER ENFIT

    MDR report key: 8578192 · Received May 3, 2019

    Report

    Report Number
    8010042-2019-00305
    Event Type
    Death
    Date Received
    May 3, 2019
    Date of Event
    April 11, 2019
    Report Date
    September 12, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 24 WEEK +2 PREMATURE PATIENT WAS EXTUBATED AND WAS SET TO BE VENTILATED IN THE NIV NAVA (NON INVASIVE VENTILATION NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION. THE ENFIT EDI CATHETER WAS INSERTED INTO THE PATIENT AND THE EDI SIGNAL WAS MONITORED AND THE ENFIT EDI CATHETER WAS LEFT IN PLACE. HOWEVER THE PATIENT BECAME UNSTABLE AND WOKE UP. THE PATIENT SUFFERED FROM BAD ACIDOSIS. THE STOMACH WAS FULL OF AIR AND THE PATIENT WAS ALL PINK. THE BREATHING WAS VERY DIFFICULT. THE STOMACH COULD NOT BE EMPTIED. AN X-RAY IMAGE WAS TAKEN AND IT SHOWED THAT ENFIT EDI CATHETER WAS IN THE WRONG PLACE BEHIND THE STOMACH. THE STOMACH WAS THEREFORE PRESSING THE LUNGS AND THE DIAPHRAGM THUS MAKING BREATHING DIFFICULT. THE ENFIT EDI CATHETER WAS REMOVED AND THE PATIENT WAS RE-INTUBATED. AFTER REINTUBATION THE INSERTION OF A SMALL NG-TUBE WAS UNSUCCESSFUL BUT LATER A LARGER NG TUBE WAS SUCCESSFULLY INSERTED. INTRAVENOUS ANTIBIOTIC TREATMENT WAS STARTED. THE PATIENT¿S INTENSIVE CARE TREATMENT CONTINUED FOR 1½ DAYS AND THE PATIENT DIED. MANUFACTURER REFERENCE#: (B)(4).

    Additional Manufacturer Narrative · 1

    THE FACILITY STATED THAT THE ENFIT EDI CATHETER FOR NAVA HEREAFTER CALLED CATHETER WAS POSITIONED PROPERLY, WORKED NORMALLY AND NOT SO MANY ALARMS WERE GENERATED. THE FIRST INSERTION ATTEMPT FAILED AND IT WAS THE SECOND NURSE WHO INSERTED CATHETER. THE INSERTION PROCEDURE AND INFORMATION OF HOW THE INSERTION WAS DONE RECEIVED FROM THE HOSPITAL INDICATES THAT IT WAS DONE CORRECTLY BUT THIS HAS NOT BEEN VERIFIED WITHOUT THE POSITIONING WINDOW PICTURES. THE CATHETER WAS NOT RETURNED BUT THERE IS NO ALLEGATION THAT IT HAD ANY PHYSICAL OR SIGNAL PICKING FAULT. THE X-RAY PICTURES WITH THE CATHETER IN THE PATIENT SHOW THAT IT WAS MAL-POSITIONED. THE LOGS FROM THE VENTILATOR THAT WAS BEING USED WITH THE CATHETER SHOW THAT NAVA VENTILATION LASTED 3 HOURS 20 MINUTES AND CONTAINS NUMEROUS ALARMS. THE ANALYSIS OF THE LOGS INDICATE THAT THE EDI CATHETER WAS ALL ALONG IN THE WRONG POSITION. WHAT WAS PERCEIVED AS EDI THE SIGNALS CONSISTED OF ONLY ECG-ARTEFACTS THAT WERE PICKED UP SIMULTANEOUSLY AND IN A RATE CORRESPONDING TO QRS-COMPLEX. A REVIEW OF THE USER¿S MANUAL SHOWS THAT THE INFORMATION CONTAINED THEREIN FOR INSERTION AND POSITIONING OF THE CATHETER IS ADEQUATE. THE CONCLUSION IN THE MATTER IS THAT THERE WAS NO EDI CATHETER OR A VENTILATOR MALFUNCTION AT THE TIME. THE EDI CATHETER PERFORATED THE ESOPHAGUS DURING INSERTION AND WAS WRONGLY PLACED. THE VENTILATOR ALARMED FOR THE SITUATION BUT NO MEASURES WERE TAKEN. THE CAUSE WAS MAL-POSITIONING AND MISINTERPRETATION OF NAVA BY THE OPERATOR AT THE TIME.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371629 EDI CATHETER ENFIT GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA Death