BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3169180 · Received June 14, 2013

    Report

    Report Number
    9611451-2013-00470
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR EVALUATION: RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT (LOT INFORMATION NOT PROVIDED), MR290V VENTED HUMIDIFICATION CHAMBER (LOT 1211200105; DATE OF MANUFACTURE: 20 NOV 2012), MR850 RESPIRATORY HUMIDIFIER (LOT 061110028344; DATE OF MANUFACTURE: 10 NOV 2006). METHOD: THE RT340 BREATHING CIRCUIT AND THE MR290V CHAMBER WERE VISUALLY INSPECTED AND THE DIMENSIONS OF THE INSPIRATORY LIMB CONNECTOR ON THE RT340 BREATHING CIRCUIT WERE CHECKED TO SEE IF THEY WERE WITHIN SPECIFICATION. OUR RECORDS FOR THE MR290V CHAMBER AND THE RT340 BREATHING CIRCUIT WERE ALSO INSPECTED. FURTHERMORE, THE MR850 WAS PERFORMANCE TESTED ACCORDING TO THE MR850 TECHNICAL MANUAL. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE INSPIRATORY LIMB CONNECTOR ON THE RETURNED RT340 BREATHING CIRCUIT OR THE CHAMBER PORTS ON THE RETURNED MR290V CHAMBER. MEASUREMENT OF THE INSPIRATORY LIMB CONNECTOR ON THE RT340 BREATHING CIRCUIT IDENTIFIED THAT IT WAS WITHIN SPECIFICATION. A REVIEW OF OUR RECORDS DID NOT IDENTIFY ANY ISSUES RELATED TO OUT OF SPECIFICATION TAPERS ON THE INSPIRATORY LIMB CONNECTOR. IN ADDITION, A REVIEW OF ALL IN PROCESS TESTS CARRIED OUT ON MR290V CHAMBERS MANUFACTURED ON 20 NOVEMBER 2012 REVEALED THAT ALL TESTS WERE PASSED WITH NO ISSUES. THE PERFORMANCE CHECK OF THE MR850 REVEALED NO FAULT WITH THE OPERATION OF THE RETURNED HUMIDIFIER. INFORMATION FROM DRAGER, THE MANUFACTURER OF THE VENTILATOR USED AT THE TIME OF THE REPORTED INCIDENT, STATES THAT CONTINUOUS ALARMS WERE GENERATED BY THE VENTILATOR DUE TO A LEAK IN THE BREATHING CIRCUIT (DISCONNECTED OR PARTLY DISCONNECTED HOSE TO HUMIDIFIER). FURTHER INVESTIGATION BY DRAGER REVEALED THAT THE HOSPITAL STAFF PRESSED THE O2 ENRICHMENT/SUCTION BUTTON, WHICH HAS THE EFFECT OF MUTING THE VENTILATOR ALARMS. A LOT CHECK REVEALED NO COMPLAINTS OF THIS NATURE FOR LOT 121120 OR LOT 061110. CONCLUSION: NO FAULT WAS FOUND WITH ANY OF THE RETURNED DEVICES. THE CONNECTORS ON THE RT340 BREATHING CIRCUIT AND THE CHAMBER PORTS ON THE MR290V CHAMBER ARE STANDARD TAPER CONNECTIONS THAT COMPLY WITH THE REQUIREMENTS OF ISO 5356-1 "ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS". THE HOSPITAL HAS REPORTED THAT THE PATIENT WAS MOVED FROM SIDE TO SIDE DURING THE PATIENT'S WASH AND TO CHANGE THE BED LINEN PRIOR TO THE REPORTED CARDIAC ARREST. THE DISCONNECTION WAS MOST LIKELY DUE TO THE PATIENT BEING MOVED OR MOVEMENT OF STAFF AROUND THE PATIENT WHILE CHANGING THE BED LINEN OR DURING THE CARDIAC MASSAGE. THE DRAGER VENTILATOR ALARMED FOR THE REPORTED DISCONNECTION AS EXPECTED, HOWEVER STEPS TAKEN BY HOSPITAL STAFF HAD THE EFFECT OF MUTING THOSE ALARMS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RECENTLY RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. OUR INVESTIGAITON IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    THE HOSPITAL STAFF AT (B)(6) REPORTED AN INCIDENT INVOLVING A PATIENT ON A SET UP WHICH INCLUDED A DRAGER EVITA XL VENTILATOR, FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER, MR290V HUMIDIFICATION CHAMBER AND AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THE HOSPITAL STAFF REPORTED THAT AT 7:50, DURING THE PATIENT'S WASH, THE PATIENT WAS TURNED ON TO HIS RIGHT HAND SIDE AND THEN ON TO HIS LEFT HAND SIDE TO REMOVE THE BED LINEN. THE PATIENT WAS THEN PUT ON HIS BACK. THE HOSPITAL STAFF REPORTED THAT THE PATIENT'S BLOOD PRESSURE WAS "FELT AT 40 AND THEN AT 20 MM" AND THE NORADRENALIN ADMINISTERED TO THE PATIENT WAS INCREASED FROM 5.8MG TO 6MG. THE HOSPITAL FURTHER REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST AT 8:10 AND A HEART MASSAGE WAS IMMEDIATELY STARTED. THE PATIENT WAS ADMINISTERED 1MG INJECTION OF ADRENALINE. THE HOSPITAL STATED THAT NO ALARMS WERE HEARD DURING THESE EVENTS. ONCE THE HEART MASSAGE WAS STOPPED ONE OF THE DOCTORS NOTICED THAT THE INSPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS DISCONNECTED FROM THE MR290 HUMIDIFICATION CHAMBER. THE PATIENT WAS REPORTED TO HAVE DIED.

    Description of Event or Problem · 1

    THE HOSPITAL STAFF AT HOSPITAL (B)(6)REPORTED AN INCIDENT INVOLVING A PATIENT ON A SET UP WHICH INCLUDED A DRAGER EVITA XL VENTILATOR, FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER, MR290V HUMIDIFICATION CHAMBER AND AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THE HOSPITAL STAFF REPORTED THAT AT 7:50, DURING THE PATIENT'S WASH, THE PATIENT WAS TURNED ON TO HIS RIGHT HAND SIDE AND THEN ON TO HIS LEFT HAND SIDE TO REMOVE THE BED LINEN. THE PATIENT WAS THEN PUT ON HIS BACK. THE HOSPITAL STAFF REPORTED THAT THE PATIENT'S BLOOD PRESSURE WAS "FELT AT 40 AND THEN AT 20 MM" AND THE NORADRENALIN ADMINISTERED TO THE PATIENT WAS INCREASED FROM 5.8MG TO 6MG. THE HOSPITAL FURTHER REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST AT 8:10 AND A HEART MASSAGE WAS IMMEDIATELY STARTED. THE PATIENT WAS ADMINISTERED 1MG INJECTION OF ADRENALINE. THE HOSPITAL STATED THAT NO ALARMS WERE HEARD DURING THESE EVENTS. ONCE THE HEART MASSAGE WAS STOPPED ONE OF THE DOCTORS NOTICED THAT THE INSPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS DISCONNECTED FROM THE MR290 HUMIDIFICATION CHAMBER. THE PATIENT WAS REPORTED TO HAVE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271073 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MR290 HUMIDIFICATION CHAMBER| MR850 RESPIRATORY HUMIDIFIER| DRAGER EVITA XL| DRAGER EVITA XL| FPH MR850 RESPIRATORY HUMIDIFIER| FPH MR290 HUMIDIFICATION CHAMBER