BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL HEATED ADULT BREATHING CIRCUIT

    MDR report key: 1031118 · Received April 18, 2008

    Report

    Report Number
    9611451-2008-00172
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT MENTIONED IN THE COMPLAINT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. METHOD: THE RESISTANCE OF THE HEATERWIRE IN THE EXPIRATORY TUBE OF THE BREATHING CIRCUIT WAS TESTED. AN EXPIRATORY HEATERWIRE ADAPTOR WAS ALSO ATTACHED TO THE EXPIRATORY TUBE TO CHECK IT FITTED. RESULTS: THE RESISTANCE OF THE HEATERWIRE WAS WITHIN SPECIFICATION AND THE HEATERWIRE ADAPTOR FITTED ONTO THE EXPIRATORY LIMB WITHOUT FAULT. CONCLUSION: NO FAULT FOUND WITH THE BREATHING CIRCUIT. EXTERNAL FACTORS ARE THE MOST LIKELY CAUSE OF THIS CONDENSATION. THESE MAY BE DUE TO A SET UP ERROR WHERE EITHER ONLY A SINGLE LIMB HEATER WIRE ADAPTOR WAS USED, OR THE EXPIRATORY SIDE OF A DUAL HEATERWIRE ADAPTOR WAS NOT PROPERLY CONNECTED TO THE EXPIRATORY LIMB. EXTERNAL FACTORS MAY ALSO HAVE BEEN INTRODUCED BY THE ENVIRONMENT. FOR EXAMPLE, THERE MAY HAVE BEEN EXCESSIVE COOLING IN THE EXPIRATORY LIMB DUE TO A FAN DIRECTED AT THE CIRCUIT OR COOLER AIR SURROUNDING THE EXPIRATORY LIMB. THIS COOLING WOULD IMPAIR THE ABILITY OF THE LIMB TO PRODUCE ENOUGH HEAT TO PREVENT CONDENSATION. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE OF 0.0021% WORLDWIDE FOR THE PAST YEAR. THERE IS CURRENTLY A CAPA OPEN RELATING TO CONDENSATION IN CIRCUITS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN GERMANY REPORTED TO OUR DISTRIBUTOR THAT AFTER LESS THAN 24 HRS OF USING AN RT200 ADULT BREATHING CIRCUIT IN COMBINATION WITH AN MR850 AND SERVO-I VENTILATOR, CONDENSATION HAD BUILT UP IN THE EXPIRATORY TUBE SO THAT THE FLUID WATER SLOSHED INTO THE END EXPIRATORY FILTER (RT019). THIS CAUSED A TOTAL FAILURE DURING THE RESPIRATORY THERAPY, AND THE NURSE HAD TO CHANGE THE COMPLETE SYSTEM. WHILE THE SYSTEM WAS BEING CHANGED THE PT REQUIRED ARTIFICIAL RESPIRATION VIA A BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL HEATED ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200 071219

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R SERVO-I VENTILATOR