BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2035662 · Received April 1, 2011

    Report

    Report Number
    9611451-2011-00211
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 510(K): THE RT102 IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K983112. NARRATIVE: METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RECEIVED IN AN UNSEALED BAG. THE CIRCUIT WAS VISUALLY INSPECTED FOR MISSING COMPONENTS. RESULTS: AN ADAPTOR WAS FOUND TO BE MISSING FROM THE DRYLINE COMPONENT OF THE BREATHING CIRCUIT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100301. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. IT IS LIKELY THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED ADAPTOR. OUR MONITORING AND TRENDING OF INCORRECT OR MISSING BREATHING CIRCUIT COMPONENTS HAS A RATE OF OCCURRENCE OF 32 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF (B)(6) 2011.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT PARTS WERE FOUND TO BE MISSING FROM AN RT102 BREATHING CIRCUIT KIT. THE MISSING COMPONENTS WERE IDENTIFIED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT102 100301

    Patients

    Seq Age Sex Outcome Treatment
    1