BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2695136 · Received August 13, 2012

    Report

    Report Number
    9611451-2012-00554
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 19, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 101027,120210, 120320, 120326, MANUFACTURING DATE: 10/27/2010, 02/10/2012, 03/20/2012, 03/26/2012, QUANTITY AFFECTED: (B)(4). METHOD: THE 12 COMPLAINT RT240 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) FOR INSPECTION. THE RETURNED DEVICES WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE 12 RETURNED BREATHING CIRCUITS EACH HAD A HOLE ON THE DRYLINE TUBE. EACH HOLE WAS LOCATED EITHER 4.5 CM OR 10 CM FROM THE DRYLINE CONNECTOR. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINT FOR LOT NUMBER 101027. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINTS FOR LOT NUMBER 120210. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINTS FOR LOT NUMBER 120320. A LOT CHECK REVEALED (B)(4) OTHER COMPLAINT FOR LOT NUMBER 120326. CONCLUSION: IT WAS IDENTIFIED THAT DAMAGE TO THE RT240 DRYLINE TUBE COULD HAVE BEEN CAUSED DURING THE MANUFACTURING PROCESS. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY 10 MINUTES AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT240 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "VERIFY THAT VENTILATOR ALARMS ARE SET TO DETECT LOSS OF PRESSURE AND OVER PRESSURE." (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO OUR DISTRIBUTOR THAT 12 UNITS OF RT240 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS "ARE NOT PASSING THE LEAK TEST". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT240 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1