BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1762772 · Received June 25, 2010

    Report

    Report Number
    9611451-2010-00402
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Report Date
    May 28, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT DATES AND CORRESPONDING DEVICE MANUFACTURE DATES OF THE COMPLAINT DEVICES: 100305 -3/5/10 (2 DEVICES), 100306 -3/6/10, 100311 -3/11/10. METHOD: THE DEVICES WERE NOT RETURNED TO THE MFR FOR INSPECTION. THE INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND A PHOTOGRAPH PROVIDED BY THE CUSTOMER. RESULTS: THE INVESTIGATION CONFIRMED THAT ONLY ONE ADAPTER WAS ASSEMBLED ONTO THE PRESSURE LINE OF THE BREATHING CIRCUIT. THE SAID PRESSURE LINE SHOULD HAVE TWO ADAPTERS, ONE AT EACH END. LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBERS 100305, 100306, AND 100311. CONCLUSION: THE BREATHING CIRCUIT PACKAGE CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT ONE OF THE PRESSURE LINE ADAPTORS WAS OMITTED DURING THE ASSEMBLY PROCESS. THERE ARE STANDARD OPERATING PROCEDURES IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED, WHICH MUST BE DISPLAYED AT THE PACKING STATION. THE MISSING ADAPTORS WERE NOTICED DURING THE INWARDS GOODS INSPECTION BY THE DISTRIBUTOR. THE DISTRIBUTOR/MFR REPROCESSES AND REPACKAGES THIS PRODUCT BEFORE SELLING IT TO THE END USER. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT FOUR RT132 INFANT BREATHING CIRCUIT KITS WERE MISSING A PRESSURE LINE CONNECTOR. THIS WAS OBSERVED DURING AN INWARD GOODS INSPECTION, PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT132 100305

    Patients

    Seq Age Sex Outcome Treatment
    1