BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2028153 · Received March 23, 2011

    Report

    Report Number
    9611451-2011-00188
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 23, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFE TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PMA/510(K): THIS PRODUCT 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. METHOD: ONLY ONE RT104 ADULT DUAL-HEATED BREATHING CIRCUIT KIT WAS RETURNED TO FPH (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR A MISSING TUBE. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBE WAS NOT MISSING BUT RATHER AN INCORRECT TYPE OF EXPIRATORY TUBE HAS BEEN PACKED WITH THE BREATHING CIRCUIT KIT. A LOT CHECK REVEALED THREE OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100624. CONCLUSION: THE BREATHING CIRCUIT PACKAGE CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS MOST LIKELY THAT OPERATOR ERROR HAS RESULTED IN AN INCORRECT TYPE OF EXPIRATORY TUBE HAVING BEEN PACKED WITH THIS BREATHING CIRCUIT. THIS IS MOST LIKELY DUE TO A FAULT IN THE LINE CLEARANCE PROCESS. THE STANDARD OPERATING PROCEDURES (SOPS) HAVE BEEN PUT IN PLACE TO ASSIST THE OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK BREATHING CIRCUITS. A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED MUST BE DISPLAYED AT THE PACKING STATION. EACH COMPLETED CIRCUIT PACK IS THEN WEIGHED TO ENSURE THAT EVERY COMPONENT IS ACCOUNTED FOR. THE PACK CARD IS CHANGED AS PART OF THE LINE CLEARANCE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE "EXTENSION TUBE" OF AN EXPIRATORY LIMB WAS NOT INCLUDED IN EACH OF THE FOUR RT104 ADULT DUAL-HEATED BREATHING CIRCUIT KITS. THIS WAS NOTICED BEFORE PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT104 100624

    Patients

    Seq Age Sex Outcome Treatment
    1