BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9681900-1998-00027

    MDR report key: 168141 · Received May 18, 1998

    Report

    Report Number
    9681900-1998-00027
    Event Type
    Injury
    Date Received
    May 18, 1998
    Report Date
    April 21, 1998
    Product Code
    CAE
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MFR REC'D A COPY OF A REPORT ENTITLED "PULMONARY ASPIRATION OF BLOOD FOLLOWING TRAUMATIC LARYNGEAL MASK AIRWAY INSERTION" FROM AUSTRALIAN JOURNAL ANAESTHESIA AND INTENSIVE CARE, 1998; 26:213-215, AUTHORED BY A. NORTON, ET. AL. THE REPORT DESCRIBES THE CASE OF A 62 Y/O FEMALE WHO UNDERWENT A SIZE 3 LMA, WHICH WAS INFLATED WITH 5ML OF AIR PRIOR TO INSERTION. REPORT DESCRIBES "BLEEDING DUE TO TRAUMATIC LARYNGEAL MASK INSERTION." AUTHORS CONCLUDE THAT CASE HIGHLIGHTS TWO ISSUES RELATING TO USE OF LMA. 1) "TRAUMA TO PHARYNX FOLLOWING LMA INSERTION CAN LEAD TO SIGNIFICANT AIRWAY BLEEDING," AND 2) "LMA DOES NOT NECESSARILY PREVENT SOILING OF LOWER AIRWAY, ESPECIALLY IF MASK IS MALPOSITIONED. A COMPLETE REVIEW OF REPORT BY DRS. OF THE DEPT OF ANAESTHESTICS AT FACILITY REVEALS NUMEROUS MISTAKES IN USE OF LMA. IN A LETTER TO CHIEF EDITOR OF ANAESTHESIA AND INTENSIVE CARE, DRS. WRITE: "...REPORT BY NORTON SUGGESTS THAT THEIR METHOD OF INSERTION AND SUBSEQUENT MANAGEMENT OF LMA CONTRIBUTED TO IT BEING INCORRECTLY POSITIONED AND THUS LED TO ASPIRATION OF BLOOD INTO TRACHEA. FIRSTLY, THEIR USE OF A SIZE 3 LMA, WHICH IS INDICATED FOR OLDER PEDIATRIC PATIENTS, WAS INAPPROPRIATE IN THIS ADULT FEMALE PT, WHICH RESULTED IN AN EXCESSIVE VOLUME OF AIR FOR CUFF INFLATION. SECONDLY, THE LMA WAS INSERTED WITH THE CUFF PARTIALLY INFLATED WITH AIR, WHICH IS CONTRARY TO THE RECOMMENDATIONS OF THE INVENTOR AND MFR OF DEVICE. THIRDLY, THEY FAILED TO MONITOR CUFF PRESSURE OVER 45 MINUTES OF NITROUS OXIDE ANAESTHESIA AND ACCUMULATION OF NITROUS OXIDE IN CUFF MAY HAVE EXAGGERATED ANY PRE-EXISTING MALPOSITION CAUSED BY FIRST TWO FACTORS. CONSIDERING THESE FACTORS, IT IS MORE LIKELY THAT ASPIRATION OF BLOOD WAS DUE TO A FAILURE TO USE LMA CORRECTLY, RATHER THAN TO ANY INHERENT DEFECT IN DEVICE. AN INAPPROPRIATELY SIZED ENDOTRACHEAL TUBE INSERTED INCORRECTLY, WITH CUFF INCORRECTLY INFLATED, WHICH BECOMES DISPLACED BY SURGICAL DRAPES, WILL ALSO FAIL TO PROVIDE PROTECTION OF LOWER AIRWAY. AUTHOR WOULD RE-EMPHASIZE THAT AN APPROPRIATELY SIZED LMA CORRECTLY INSERTED FACILITATES CORRECT POSITIONING OF TIP OF CUFF AT UPPER ESOPHAGEAL-SPHINCTER AND WHEN PROPERLY SECURED WILL PROVIDE A SAFE AND ADEQUATE AIRWAY WHICH PROTECTS LOWER AIRWAY FROM SOILING FROM ABOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR