BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2280982 · Received October 6, 2011

    Report

    Report Number
    9611451-2011-00626
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Report Date
    September 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. THE COMPLAINT DEVICE HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND THE DEVICE EVALUATION IS CURRENTLY IN PROGRESS AS WE ARE ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION. DEVICE EVALUATION CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. METHOD: THE COMPLAINT RT265 INFANT BREATHING CIRCUIT HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR INSPECTION. RESULT: THE VISUAL INSPECTION REVEALED THAT THE EVAQUA2 (EXPIRATORY) LIMB WAS EVENLY DISCOLORED. IT IS ALSO NOTED THAT THERE WAS A POWDERY RESIDUE ON THE SWIVEL ONLY. AN EXTERNAL LABORATORY TEST RESULT REVEALED THAT THE MAJOR COMPONENTS OF THE POWDERY RESIDUE WERE CARBOXYLIC ACID AND AMIDE COMPOUNDS. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DISCOLORATION. THE EXTERNAL LABORATORY TEST RESULT INDICATES THAT THE RESIDUE ON THE SWIVEL MAY BE CAUSED BY HUMAN SECRETION OR A TYPE OF DRUG USAGE. THE CUSTOMER ALSO REPORTED THAT THE COMPLAINT DEVICE WAS USED FOR APPROXIMATELY 15 DAYS, WHICH EXCEEDS THE MAXIMUM PERIOD OF INTENDED USE OF 7 DAYS. IT IS POSSIBLE THAT THIS PROLONGED USAGE MAY HAVE CONTRIBUTED TO THE DISCOLOURATION. THE USER INSTRUCTIONS PROVIDED WITH THE RT265 INFANT BREATHING CIRCUIT STATES: "THIS PRODUCT IS INTENDED TO BE USED FOR A MAXIMUM OF 7 DAYS." "REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES, INTERRUPTION TO TREATMENT, SERIOUS HARM OR DEATH."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE SALES REPRESENTATIVE THAT THE EXPIRATORY LIMB OF AN RT265 INFANT BREATHING CIRCUIT KIT WAS DISCOLORED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE SALES REPRESENTATIVE THAT THE EXPIRATORY LIMB OF AN RT265 INFANT BREATHING CIRCUIT KIT WAS DISCOLORED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265

    Patients

    Seq Age Sex Outcome Treatment
    1 SLE5000 VENTILATOR