BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 3032940 · Received April 1, 2013

    Report

    Report Number
    9611710-2013-00238
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT A REOCCURRENCE OF THIS MALFUNCTION IS LIKELY TO CONTRIBUTE TO OR LEAD TO A SERIOUS INJURY/ILLNESS TO THE PATIENT: AN ENDOTRACHEAL TUBE WHOSE CUFF BULGES (HERNIATES) INTO THE LUMEN RESULTING IN AN OCCLUSION OF THE LUMEN IS LIKELY TO LEAD TO OR CONTRIBUTE TO A SERIOUS INJURY/ILLNESS TO A PATIENT SHOULD THE MALFUNCTION RECUR. A BLOCKED ETT WOULD NOT PERMIT THE ADEQUATE VENTILATION OF A PATIENT AND THIS MAY HAVE SERIOUS HEALTH CONSEQUENCES. BASED ON THE INVESTIGATION, THE OBSTRUCTION OF THE LUMEN WAS CONFIRMED. THE NOTCH LOCATION IS NOT AT 22MM LOCATION WHERE THE START OF THE "LAYER SWELL UP" WAS OBSERVED. NO SIGN OF MANUFACTURING DEFECT CAN BE SEEN. PER THE CUSTOMER COMPLAINT FORM IT WAS CLEARLY MENTIONED THAT THE DOCTOR INFLATE THE CUFF OF 7.0MM REIN - ETT WITH 15ML AIR, THEN AFTER 1 MINUTE LATER THE MACHINE ALARM AND FOUND THE BULGING INSIDE THE TUBE. THE INSTRUCTION FOR USE (IFU) CLEARLY STATED THAT THE FIXED AMOUNT OF AIR IS NOT RECOMMENDED TO BE USED FOR INFLATING THE CUFF AS THIS WILL BUILD UP EXCESSIVE INTRA CUFF PRESSURE LEADING TO ADVERSE CONDITION TO PATIENT AND PRODUCT. IN THE CASE REFERRED, THIS EXCESSIVE PRESSURE BUILT UP COULD HAVE AFFECTED THE PRODUCT'S DESIGN PERFORMANCE ADVERSELY. FURTHER INVESTIGATION WAS PERFORMED BY R AND D TO CORRELATE THE 12ML AIR AND 15ML OF AIR (AS APPLIED TO CUFF AT THE HOSPITAL) WITH THE INTERNAL CUFF PRESSURE. WHEN FIXED AMOUNT OF AIR (12ML) IS USED IN INFLATING THE UNHINDERED CUFF, THE INTRA CUFF PRESSURE IS BETWEEN 60 TO 0 CM H2O. THE SAME AMOUNT OF AIR (12ML) WILL CREATE AN INTRA CUFF PRESSURE OF 210 TO 306 CM H2) WHEN THE STANDARD TUBE IS USED TO RESIST THE EXPANSION OF THE BALLOON WHILE BEING INFLATED. THE INTRA CUFF PRESSURE WHEN 15ML IS INFLATED INTO THE CUFF IS MEASURED BUT SINCE THE INSTRUMENT CAPABILITY IS LIMITED TO 300 CM H2O, ERROR MESSAGES APPEAR IMPLYING THE INTRA CUFF PRESSURE ABOVE THE MAX DISPLAY LEVEL OF THE INSTRUMENT. THIS CORRELATES TO THE RECOMMENDATIONS IN THE IFU, THAT FIXED AMOUNT OF AIR IS NOT RECOMMENDED TO BE USED FOR INFLATING THE CUFF WHICH WILL BUILD UP EXCESSIVE INTRA CUFF PRESSURE LEADING TO ADVERSE CONDITION TO THE PATIENT AND PRODUCT. THE EXCESSIVE PRESSURE BUILT UP COULD HAVE AFFECTED THE PRODUCTS DESIGN PERFORMANCE ADVERSELY. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "REIN TT'S INSIDE COATING MUSTER CAUSED THE BLOCKAGE OF THE AIRWAY TUBE, ALMOST CAUSED THE PATIENT DIE DURING THE ANESTHESIA OPERATION. THE DOCTOR INFLATE THE CUFF OF 7.0MM REIN - ETT WITH 15ML AIR, THEN AFTER 1 MINUTE LATER THE MACHINE ALARM AND FOUND THE BULGING INSIDE THE TUBE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131663 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHAEL BTR UNOMEDICAL SDN BHD 61214070 611878R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening