BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2692249 · Received August 13, 2012

    Report

    Report Number
    9611451-2012-00551
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Report Date
    July 18, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 110321, 120119, MFG DATES: 03/21/2011, 01/19/2012, QUANTITY AFFECTED: 1, 1. THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 110321, 120119; MANUFACTURING DATE: 03/21/2011, 01/19/2012; (B)(4). METHOD: THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE RETURNED BREATHING CIRCUITS WERE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED THAT THE RT340 BREATHING CIRCUIT WITH LOT NUMBER 120119 HAD A HOLE IN THE EVAQUA EXPIRATORY LIMB, ABOUT 13.5CM AWAY FROM THE PROXIMAL CONNECTOR. THE PRESSURE TEST SHOWED THAT THE SUBJECT BREATHING CIRCUIT WAS OUT OF SPECIFICATION DUE TO EXCESSIVE LEAK. NO FAULT WAS FOUND WITH THE OTHER RT340 BREATHING CIRCUIT WITH LOT NUMBER 110321. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120119. CONCLUSION: IT IS LIKELY THAT THE DAMAGED EVAQUA EXPIRATORY TUBE WAS PUNCTURED DURING USE. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. (B)(4). THE USER INSTRUCTIONS SUPPLIED WITH 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." "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. 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 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1