BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFEPORT ENDOTRACHEAL TUBE ADAPTER

    MDR report key: 1880182 · Received October 7, 2010

    Report

    Report Number
    1719232-2010-00001
    Event Type
    Other
    Date Received
    October 7, 2010
    Date of Event
    August 9, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BUNNELL INC. HAS NEVER RECEIVED A COMPLAINT OF A CRACK IN THE PRESSURE MONITORING LINE OF A LIFEPORT. WE HAVE NO COMPLAINT HISTORY FOR THIS. THE USER FACILITY HAS NOT RETURNED THE LIFEPORT TO US FOR FAILURE INVESTIGATION. WE HAVE BEEN ADVISED THAT RISK MANAGEMENT HAS THIS ADAPTER AND IT IS IRRETRIEVABLE. WE ARE NOT ABLE TO CONFIRM THE REPORTED CRACK OR INVESTIGATE THE POSSIBLE CAUSE. THE USER FACILITY HAS NOT PROVIDED US WITH THE LOT NUMBER OR CATALOG NUMBER. THE CAUSE OF THE PROBLEM DESCRIBED IN THE MEDWATCH REPORT #(B)(4) FOR (B)(6) HOSPITAL WAS REPORTED TO BUNNELL AS A CRACK IN THE PRESSURE MONITORING TUBE ATTACHES TO THE LIFEPORT ADAPTER. THE LIFEPORT ADAPTER IS A SPECIAL ENDOTRACHEAL TUBE ADAPTER USED IN CONJUNCTION WITH THE LIFE PULSE HIGH FREQUENCY VENTILATOR. IT CONTAINS A PORT (THE JET PORT) FOR DELIVERING THE BREATHS CREATED BY THE LIFE PULSE VENTILATOR AND A PORT WITH A TUBE ATTACHED TO IT (THE PRESSURE MONITORING TUBE) FOR MONITORING THE AIRWAY PRESSURES. THE "BOUNCE" (PRONOUNCED CHEST RISE" REFERRED TO IN THE DESCRIPTION COULD BE CAUSED IF THERE WAS A CRACK, ALLOWING THE PRESSURE TO LEAK OUT OF THE PRESSURE MONITORING TUBE PRIOR TO IT REACHING THE PRESSURE TRANSDUCER IN THE PT BOX (FLOW INTERRUPTER VALVE THAT CREATES THE HIGH-FREQUENCY BREATHES. THE LIFE PULSE VENTILATOR IS DRIVEN BY PEAK INSPIRATORY PRESSURE (PIP) AS MONITORED THROUGH THE PRESSURE MONITORING TUBE BY THE PRESSURE TRANSDUCER IN THE PT BOX. THE FLOW THAT IS NECESSARY TO REACH THE SET PIP IS AUTOMATICALLY CONTROLLED BY THE VENTILATOR SOFTWARE THROUGH A FEEDBACK LOOP THAT COMPARES THE MONITORED PIP TO THE SET PIP. IF THERE WAS A CRACK IN THE PRESSURE MONITORING TUBE, THE MONITORED PRESSURE APPEARS LOW SO THE SOFTWARE INCREASES THE FLOW (WHICH WE DISPLAY AS SERVO PRESSURE) UNTIL THE MONITORED PIP MATCHES THE SET PIP. THE HIGHER FLOW RESULTS IN A LARGER VOLUME OF GAS BEING DELIVERED TO THE PT WITH EACH BREATH WHICH COULD CAUSE THE CHEST TO "BOUNCE". IF THE PRESSURE MONITORING TUBE IS POSITIONED IN A WAY THAT CAUSES A CRACK TO BE WIDE OPEN, THE AIRWAY PRESSURE (PIP AND PEEP) WOULD BE MONITORED AS ZERO BECAUSE NO PRESSURE WOULD REACH THE PRESSURE TRANSDUCER IN THE PT BOX. THIS MIGHT EXPLAIN WHAT HAPPENED ON THEIR SECOND ATTEMPT TO START A LIFE PULSE VENTILATOR AFTER SWITCHING VENTILATOR (UNABLE TO OBTAIN THE PEEP). IN THIS SCENARIO, THE LIFE PULSE VENTILATOR WOULD ACTIVATE A LOSS OF PIP ALARM 12 SECONDS AFTER THE VENTILATOR WAS STARTED (THE ENTER BUTTON WAS PRESSED). THE LOSS OF PIP ALARM COULD CAUSE THE FLOW CONTROL VALVE TO CLOSE AND THE PIP AND FLOW (SERVO PRESSURE) WOULD DROP TO ZERO. THIS ALARM WAS NOT REPORTED IN THE (B)(6) MEDWATCH REPORT.

    Description of Event or Problem · 1

    PLACED PT ON LIFE PULSE VENTILATOR. PT'S CHEST WIGGLE WAS VIGOROUS SO THE VENTILATOR WAS STOPPED. PT PLACED ON CONVENTIONAL VENTILATOR ONLY. TRANSILLUMINATION REVEALED LARGE LEFT-SIDE PNEUMOTHORAX. PNEUMO WAS ASPIRATED AND CHEST TUBE PLACED. LIFE PULSE VENTILATOR REPLACED WITH A BACK-UP LIFE PULSE VENTILATOR. THIS TIME THE RESPIRATORY THERAPIST NOTICED SERVO PRESSURE GOING UP BUT PIP AND PEEP WERE NOT. CHEST WAS WIGGLING AGAIN. LIFE PULSE VENTILATOR WAS REMOVED FROM PT. A CRACK WAS FOUND IN THE PRESSURE MONITORING LINE OF THE LIFEPORT ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT ENDOTRACHEAL TUBE ADAPTER ENDOTRACHEAL TUBE ADAPTER LSZ BUNNELL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other