BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1904869 · Received November 22, 2010

    Report

    Report Number
    9611451-2010-00694
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 22, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 ADULT DUAL HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE COMPLAINT RT200 ADULT DUAL HEATED BREATHING CIRCUIT WAS NOT RETURNED BY THE HOSPITAL FOR INVESTIGATION AND IS NO LONGER EXPECTED. OUR INVESTIGATION WAS CARRIED OUT BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL DURING THE VISIT BY THE FPH FIELD REPRESENTATIVE IN (B)(6). THE FPH FIELD REPRESENTATIVE REPORTED THAT THE CIRCUIT APPEARED TO HAVE BEEN INCORRECTLY SET UP. THE INSPIRATORY DRYLINE AND EXPIRATORY TUBES OF AN RT200 WERE CONNECTED TO THE VENTILATOR IN REVERSED POSITION. FOLLOWING THE REPORTED INCIDENT, THE FPH FIELD REPRESENTATIVE CONDUCTED TRAINING WITH THE HOSPITAL STAFF BY SETTING UP TWO DEMONSTRATION UNITS CONNECTED TO A TEST LUNG. THE FIRST DEMONSTRATION UNIT WAS SET UP CORRECTLY WITH THE INSPIRATORY DRYLINE CONNECTED TO THE INSPIRATORY PORT OF THE VENTILATOR AND THE EXPIRATORY TUBE TO THE EXPIRATORY PORT. THE SET-UP WORKED PROPERLY AND NO ALARM WAS GENERATED ON THE HUMIDIFIER. THE INSPIRATORY DRYLINE AND THE EXPIRATORY TUBE OF THE SECOND DEMONSTRATION UNIT WERE DELIBERATELY CONNECTED IN REVERSED POSITION. THE REPORTED FAULT WAS REPLICATED. A "RED LUNG" ALARM WAS GENERATED ON THE MR850 RESPIRATORY HUMIDIFIER. THE FPH FIELD REPRESENTATIVE FURTHER EXPLAINED TO THE HOSPITAL STAFF THE DIFFERENCE BETWEEN THE TWO SET-UPS AND THE CONSEQUENCES OF HAVING THE INSPIRATORY DRYLINE AND THE EXPIRATORY TUBE CONNECTED IN REVERSED POSITION. THE RT200 ADULT BREATHING CIRCUIT CONSISTS OF TWO BREATHING TUBES, THE INSPIRATORY TUBE WHICH IS COLOURED BLUE AND THE EXPIRATORY TUBE WHICH IS WHITE. THE FPH USER INSTRUCTIONS THAT ACCOMPANY THE RT200 BREATHING CIRCUIT INDICATE IN PICTORIAL FORM THE CORRECT WAY OF SETTING UP BOTH TUBES TO THE MR290 CHAMBER, MR850 HUMIDIFIER AND VENTILATOR. FURTHER INFORMATION RECEIVED FROM THE HOSPITAL CONFIRMED THAT THE PATIENT IS NOW IN GOOD CONDITION AND HAS BEEN TRANSFERRED FROM THE INTENSIVE CARE UNIT (ICU) TO THE HOSPITAL WARD. NO FURTHER CONSEQUENCE TO THE PATIENT WAS REPORTED AS A RESULT OF THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WHILE A PATIENT WAS ON A CENTIVA VENTILATOR WITH AN MR850AGU RESPIRATORY HUMIDIFIER, AN MR290 HUMIDIFICATION CHAMBER AND AN RT200 ADULT DUAL HEATED BREATHING CIRCUIT, THE MR850 HUMIDIFIER GENERATED A 'RED LUNG' ALARM. THE ALARM SOUNDED SEVEN TO EIGHT TIMES AT AROUND HALF AN HOUR INTERVALS. THE HOSPITAL STAFF SWITCHED THE MR850 HUMIDIFIER OFF AND ON TO DEACTIVATE THE ALARM. EACH TIME THE MR850 HUMIDIFIER WARMED UP, IT BEGAN TO ALARM AGAIN. IT WAS REPORTED TO THE FPH FIELD REPRESENTATIVE THAT THE FOLLOWING NIGHT, A PATIENT WAS FOUND TO BE RECEIVING DRY AIR AND THAT THERE WAS LUNG DAMAGE. IT WAS ALSO REPORTED THAT AN EMERGENCY LIGHT BRONCHOSCOPY SHOWED THAT THE PATIENT HAD DRY SECRETIONS, BLOOD CLOTS IN THE TRACHEA, AND A REDDENED AND ULCERATED TRACHEAL WALL. THE FPH FIELD REPRESENTATIVE WHO VISITED THE HOSPITAL REPORTED THAT THE RT200 ADULT BREATHING CIRCUIT APPEARED TO HAVE BEEN INCORRECTLY SET UP, WITH THE INSPIRATORY AND THE EXPIRATORY TUBES IN REVERSED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT200 091028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FPH MR850AGU RESPIRATORY HUMIDIFIER| FPH MR290 HUMIDIFICATION CHAMBER| CENTIVA VENTILATOR