BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT HEATED PEEP/CPAP CIRCUIT

    MDR report key: 3405489 · Received October 10, 2013

    Report

    Report Number
    9611451-2013-00795
    Event Type
    Death
    Date Received
    October 10, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 13, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT301 ADULT HEATED PEEP/CPAP CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. BACKGROUND: THE RT301 ADULT HEATED PEEP/CPAP CIRCUIT KIT IS USED TO PROVIDE CPAP THERAPY VIA A MASK (NON-INVASIVE) OR TRACHE (INVASIVE). IT INCLUDES AN ADJUSTABLE PEEP (POSITIVE END EXPIRATORY PRESSURE) VALVE. THE PEEP VALVE SHOULD BE SET BETWEEN 5 AND 15 CMH2O AS PRESCRIBED BY A DOCTOR. A FIXED PRESSURE RELIEF VALVE IS ALSO INCLUDED IN THE KIT. THIS IS SET TO 20 CMH2O AND IS NOT ADJUSTABLE. THE RT301 IS PACKAGED WITH THE ADJUSTABLE PEEP VALVE AND FIXED PRESSURE RELIEF VALVE ALREADY ASSEMBLED. METHOD: ONLY THE INSPIRATORY AND EXPIRATORY LIMBS ALONG WITH THE ADJUSTABLE PEEP VALVE AND FIXED PRESSURE RELIEF VALVE FROM THE RT301 ADULT HEATED BREATHING CIRCUIT WERE RETURNED TO FPH FOR EVALUATION. THE SWIVEL WYE PIECE, THE DRYLINE TUBE AND THE MR290 CHAMBER WERE NOT RETURNED. UPON RETURN A NOTE FROM THE HOSPITAL SPECIFIED THAT THE "DISPOSABLE FIXED RELIEF VALVE" WAS "FAULTY". THE RETURNED CIRCUIT WAS VISUALLY INSPECTED INCLUDING THE ADJUSTABLE PEEP VALVE AND THE FIXED PRESSURE RELIEF VALVE. IN ADDITION, THE FUNCTIONALITY OF THE ADJUSTABLE PEEP VALVE AND THE FIXED PRESSURE RELIEF VALVE WAS ALSO TESTED. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO ANY OF THE RETURNED COMPONENTS. NO DAMAGE OR FAULT WAS FOUND ON THE ADJUSTABLE PEEP VALVE OR THE FIXED PRESSURE RELIEF VALVE. THE FUNCTIONALITY TEST IDENTIFIED THAT THE ADJUSTABLE PEEP VALVE DELIVERED PEEP ACCORDING TO THE SETTING PRESCRIBED IN THE IFU. THE FIXED PRESSURE RELIEF VALVE WAS ACTIVATED AT THE CORRECT VALUE OF 20 CMH2O AS IDENTIFIED IN THE IFU. WE HAVE RECEIVED NO OTHER COMPLAINTS FOR THE RT301 ADULT BREATHING CIRCUIT. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED RT301 ADULT HEATED BREATHING CIRCUIT. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT301 STATE THE FOLLOWING: "ALWAYS MONITOR THE PATIENT CONDITION WHEN DELIVERING PEEP." "ALWAYS MONITOR THE AIRWAY PRESSURE WHEN ADMINISTERING PEEP." "TEST THE SYSTEM FUNCTIONALITY BEFORE USE." AN FPH REP IS IN CONTACT WITH THE HOSPITAL AND FURTHER TRAINING ON THE USE OF THE RT301 WAS OFFERED TO THE HOSPITAL STAFF. WE ALSO NOTE THAT THE RT301 ADULT HEATED BREATHING CIRCUIT IS INTENDED FOR USE WITH SPONTANEOUSLY BREATHING ADULT (>30KG) PATIENTS WITH RESPIRATORY INSUFFICIENCY WHO ARE SUITABLE FOR NONINVASIVE POSITIVE PRESSURE SUPPORT THERAPY IN HOSPITAL OR CLINICAL ENVIRONMENTS ONLY. DEPENDING ON PATIENT CONDITIONS, A DOCTOR COULD PRESCRIBE ESCALATED THERAPIES SUCH AS BI-LEVEL VENTILATION OR INVASIVE VENTILATION.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL REPORTED VIA OUR DISTRIBUTOR THAT UPON SETUP OF A PATIENT ON CPAP THERAPY WITH AN RT301 ADULT HEATED BREATHING CIRCUIT THE DEVICE DID NOT "SOUND RIGHT WHEN ON". IT WAS REPORTED THAT THE SETUP WAS CHECKED AND CPAP THERAPY WAS CONTINUED. THE PATIENT'S CONDITION DID NOT IMPROVE SO THE PATIENT WAS MOVED TO A FPH PT100. NO IMPROVEMENT WAS NOTED IN THE PATIENT'S CONDITION. IT WAS REPORTED THAT THE PATIENT WAS PLACED BACK ONTO CPAP THERAPY BUT THE SETUP DID NOT WORK PROPERLY AGAIN. THE STAFF THEN REPLACED THE RT301 ADULT HEATED BREATHING CIRCUIT WITH A NEW RT301. IT WAS REPORTED THAT THE SYSTEM WITH THE NEW RT301 "SOUNDED NORMAL". A DOCTOR WAS INFORMED OF THE SITUATION WHO INDICATED THAT THE PATIENT CONTINUE WITH THE NEW CPAP SYSTEM AND BE CONTINUALLY ASSESSED. IT WAS REPORTED THAT THE PATIENT'S CONDITION DID NOT IMPROVE AFTER ABOUT 1 HOUR. THE PATIENT WENT INTO RESPIRATORY ARREST AND PASSED AWAY. THE HOSPITAL STATED THAT THE PATIENT WAS "ALREADY DEEMED NOT FOR CPR IN THE EVENT OF CARDIAC ARREST DUE TO POOR PROGNOSIS". IT WAS FURTHER REPORTED THAT THE VALVE MECHANISM ON THE INITIAL RT301 ADULT HEATED BREATHING CIRCUIT WAS "TWISTED AND HENCE DID NOT PRODUCE A CPAP SYSTEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517613 ADULT HEATED PEEP/CPAP CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT301 120811

    Patients

    Seq Age Sex Outcome Treatment
    1 Death