BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1963196 · Received January 18, 2011

    Report

    Report Number
    9611451-2011-00038
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE RT100 IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. METHOD: THE RT100 CIRCUIT KIT WAS RETURNED IN AN UNSEALED PACKAGE. THE KIT WAS VISUALLY INSPECTED FOR MISSING COMPONENTS. RESULTS: THE Y-PIECE AND DOUBLE CLIP WERE FOUND TO BE MISSING FROM THE CIRCUIT KIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF MISSING Y-PIECE OR DOUBLE CLIP COMPONENTS FOR LOT NUMBER 100119. CONCLUSION: ALTHOUGH TWO COMPONENTS WERE FOUND TO BE MISSING FROM THE RETURNED CIRCUIT KIT, WE WERE UNABLE TO DETERMINE WHY THE COMPONENTS WERE NOT PRESENT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE MANDATORY PRESSURE TEST CANNOT BE CARRIED OUT WITHOUT THE Y-PIECE, ONE OF THE COMPONENTS THAT WAS FOUND TO BE MISSING FROM THE RETURNED CIRCUIT KIT. AS THE KIT WAS RETURNED IN AN UNSEALED PACKAGE, IT IS POSSIBLE THAT THE COMPONENTS WENT MISSING POST PRODUCTION. IN ADDITION, THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST THE OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED MUST BE DISPLAYED AT THE PACKING STATION AND THE CIRCUIT KITS ARE VISUALLY INSPECTED FOR MISSING COMPONENTS PRIOR TO DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE ADAPTOR KIT AND DRYLINE WERE MISSING FROM AN RT100 BREATHING CIRCUIT KIT. THE DISTRIBUTOR NOTICED THAT THE COMPONENTS WERE MISSING PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT100 100119

    Patients

    Seq Age Sex Outcome Treatment
    1