BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5375459 · Received January 18, 2016

    Report

    Report Number
    9611451-2016-00018
    Event Type
    Malfunction
    Date Received
    January 18, 2016
    Date of Event
    December 18, 2015
    Report Date
    December 21, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE PHOTOGRAPHS AND ADDITIONAL INFORMATION WE RECEIVED FROM THE HOSPITAL, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE PHOTOGRAPHS PROVIDED SHOWED MULTIPLE HOLES IN THE EVAQUA EXPIRATORY LIMBS. THE HOLES APPEARED TO HAVE SMOOTH EDGES. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150721. CONCLUSION: THE SUSTAINED DAMAGE TO THE EVAQUA EXPIRATORY LIMBS INDICATES THAT THEY WERE PUNCTURED WITH A SHARP OBJECT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THE SUBJECT RT265 INFANT BREATHING CIRCUITS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE AFFECTED BREATHING CIRCUITS WERE DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT."; "SET APPROPRIATE VENTILATOR ALARMS."; "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE."

    Additional Manufacturer Narrative · 1

    (B)(4) THE COMPLAINT RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR ANALYSIS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT HOLES WERE FOUND IN THE EVAQUA EXPIRATORY LIMBS OF FIVE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT HOLES WERE FOUND ON THE EVAQUA EXPIRATORY LIMBS OF FIVE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33071 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 150721

    Patients

    Seq Age Sex Outcome Treatment
    1