BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2721996 · Received August 30, 2012

    Report

    Report Number
    9611451-2012-00589
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Report Date
    August 3, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT DUAL-HEATED 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 BREATHING CIRCUIT WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: THE DRYLINE WAS FOUND TO BE MISSING FROM THE BREATHING CIRCUIT KIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120526. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED DRYLINE. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD, DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT WHEN THEY OPENED AN RT265 INFANT BREATHING CIRCUIT KIT THEY FOUND THAT THE DRYLINE TUBE WAS MISSING.

    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 120526

    Patients

    Seq Age Sex Outcome Treatment
    1