BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5296750 · Received December 14, 2015

    Report

    Report Number
    9611451-2015-00530
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    November 13, 2015
    Report Date
    November 16, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. MANUFACTURER NARRATIVE: METHOD: THE COMPLAINT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(6) FOR INSPECTION. IT WAS VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED FOR LEAKS. RESULTS: NO DAMAGE WAS NOTICED AT THE CONNECTION BETWEEN THE LIMBS AND THE SWIVEL WYE OF THE RETURNED BREATHING CIRCUIT. HOWEVER, THE EVAQUA EXPIRATORY LIMB WAS OBSERVED TO BE PARTLY PULLED OUT FROM THE PATIENT END CONNECTOR. THE PRESSURE TEST RESULT WAS WITHIN SPECIFICATION. BOTH THE INSPIRATORY AND THE EVAQUA EXPIRATORY LIMBS DID NOT DISCONNECT FROM THE SWIVEL WYE DURING PRESSURE TEST. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150404. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE LOOSE CONNECTION THAT WAS REPORTED BY THE HOSPITAL. HOWEVER, IT IS POSSIBLE FOR THE DISCONNECTION TO OCCUR IF THE TUBING IS PULLED, INSTEAD OF THE CONNECTOR, WHEN REMOVING THE BREATHING CIRCUIT FROM THE VENTILATOR. ALL RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION BEFORE IT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE CIRCUIT AND SWIVEL WYE OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT HAD LOOSE CONNECTION. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824474 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT268 150404

    Patients

    Seq Age Sex Outcome Treatment
    1