BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1133420 · Received August 22, 2008

    Report

    Report Number
    9611451-2008-00497
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAKEL HEALTHCARE BY A DISTRIBUTOR IN (B) (4). THE PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. METHOD: THE RT125 BREATHING CIRCUIT WAS NOT RETURNED TO THE MFR. AN ANALYSIS WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS. RESULTS: OPERATOR ERROR DURING THE PACKAGING PROCESS RESULTED IN FAILURE TO PACK ALL THE REQUIRED COMPONENTS IN THE ADAPTER BAG. THE CIRCUIT PACK APPEARS TO HAVE ALSO PASSED VISUAL INSPECTION FOR MISSING COMPONENTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: A CAPA WAS IMPLEMENTED AND NEW STANDARD OPERATING PROCEDURES (SOPS) PUT 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. 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. THE EFFECTIVENESS OF THE IMPROVEMENTS IMPLEMENTED ARE BEING MONITORED TO DETERMINE IF FURTHER IMPROVEMENTS ARE NECESSARY. (B) (4).

    Description of Event or Problem · 1

    OUR DISTRIBUTOR IN (B) (4) DETECTED, DURING ITS (B) (4) INSPECTION, THAT A CROSS-SHAPED CONNECTOR WAS MISSING FROM AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT125 080613

    Patients

    Seq Age Sex Outcome Treatment
    1