BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2622080 · Received June 19, 2012

    Report

    Report Number
    9611451-2012-00407
    Event Type
    Malfunction
    Date Received
    June 19, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 28, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONLY THE DRYLINE TUBE OF THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HOLE ABOUT 10CM AWAY FROM THE CONNECTOR OF THE RETURNED DRYLINE TUBE. A LOT CHECK REVEALED THREE OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120127. CONCLUSION: IT WAS IDENTIFIED THAT DAMAGE TO THE RT340 DRYLINE TUBE COULD HAVE BEEN CAUSED DURING THE MANUFACTURING PROCESS, ALTHOUGH IT IS NOT A BATCH RELATED ISSUE. 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 RT340 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." "SET APPROPRIATE VENTILATOR ALARMS." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. IT WAS ALSO REPORTED THAT A PINHOLE WAS FOUND IN THE DRYLINE TUBE. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 120127

    Patients

    Seq Age Sex Outcome Treatment
    1