BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 7739940 · Received August 1, 2018

    Report

    Report Number
    8010042-2018-00393
    Event Type
    Death
    Date Received
    August 1, 2018
    Date of Event
    June 3, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION INTO THIS COMPLAINT HAS BEEN COMPLETED. THE INFORMATION AVAILABLE SHOWS THE COURSE OF EVENTS AS BILLETED BELOW. WHILE THE ATTENDING NURSE WAS DOING A POSTURE CHANGE OF THE PATIENT, THE NG TUBE FOR NAVA ACCIDENTALLY GOT MOVED BUT NOT EXTUBATED. THE NURSE WITHOUT FURTHER CONSULTATION PUSHED BACK THE NG TUBE FOR NAVA TO WHAT THE NURSE THOUGHT WAS THE CORRECT ORIGINAL POSITION. THE NURSE CONTINUED WITH THE PRESCRIBED ENTERAL NUTRITION THROUGH THE NG TUBE. THE NURSE OBSERVED ENTERAL FEEDING CONTENT THROUGH THE ENDOTRACHEAL TUBE AND THE FEEDING WAS STOPPED. A DIRECT LARYNGOSCOPY BY THE ON-CALL PHYSICIAN SHOWED THAT THE NG TUBE FOR NAVA WAS IN THE LUNG INSTEAD OF THE ESOPHAGUS. THE FEEDING SOLUTION PROBABLY CAUSED A PNEUMONITIS THAT PROGRESSED TO SEVERE ARDS, MULTISYSTEM ORGAN FAILURE,AND DEATH. THE INSERTION AT THE HOSPITAL FOR NAVA NG TUBES IS DONE BY PHYSICIAN WHO ALSO DOES THE NECESSARY CHECKS AND TESTS TO VERIFY THE CORRECT POSITION. THERE WAS NO MALFUNCTION FOR THE NG TUBE FOR NAVA OR INADEQUATE LABELING/INSERTION/POSITIONING INFORMATION. ALTHOUGH THE NG TUBE FOR NAVA HAD NOT COMPLETELY EXTUBATED, IT HAD MOVED OUT FROM THE ESOPHAGUS AND HAD REQUIRED A FULL INSERTION PROCEDURE INCLUDING CHECKS AND TESTS THAT REQUIRED A PHYSICIAN. THE CAUSE OF THE EVENT WAS THE NON-FOLLOWING OF THE HOSPITAL INSERTION PROCEDURES. 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 PERSON: (B)(4).

    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 PERSON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE ATTENDING NURSE WAS DOING A POSTURAL CHANGE, THE NG TUBE FOR NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) WAS ACCIDENTALLY MOVED, WITHOUT VISUAL EVIDENCE THAT IT WAS COMPLETELY REMOVED FROM THE ESOPHAGUS. WITH THE BEST OF INTENTIONS, THE ATTENDING NURSE ADVANCED THE NG TUBE FOR NAVA. THE NURSE INDICATED THAT SHE HEARD THE SOUND OF INSUFFLATED AIR IN THE ABDOMEN WITH A STETHOSCOPE, BUT AN X-RAY WAS NOT IMMEDIATELY OBTAINED. LATER, THE NURSE OBSERVED ENTERAL FEEDING CONTENT THROUGH THE ENDOTRACHEAL TUBE. THE ENTERAL FEEDING WAS STOPPED AND A DIRECT LARYNGOSCOPY BY THE ON-CALL PHYSICIAN SHOWED THAT THE NG TUBE FOR NAVA WAS IN THE LUNG. THE NG TUBE FOR NAVA CATHETER WAS COMPLETELY REMOVED AND FULL VENTILATOR SUPPORT WAS INDICATED. THE PATIENT SUFFERED A PNEUMONITIS THAT PROGRESSED TO SEVERE ARDS, MULTISYSTEM ORGAN FAILURE, AND DEATH. DEATH WAS CAUSED BY CARDIAC TAMPONADE AFTER CANNULATION FOR ECMO. MANUFACTURER REFERENCE#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582421 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death