BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3870563 · Received June 12, 2014

    Report

    Report Number
    9611451-2014-00496
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON INFORMATION RECEIVED FROM THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED BY THE HOSPITAL. RESULTS: WE WERE UNABLE TO IDENTIFY THE CAUSE OF THE REPORTED INCIDENT WITHOUT THE RETURN OF THE COMPLAINT (RT265. CONCLUSION: THE CONNECTIONS OF THE RT265 CIRCUIT ARE DESIGNED TO CONFORM TO THE RELEVANT ISO STANDARDS FOR THIS TYPE OF DEVICE. THE CONNECTIONS OF THE INSPIRATORY AND EXPIRATORY LIMBS ARE A STANDARD 1 IN (B)(4) MEDICAL TAPER-FIT AND THE PRESSURE LINE IS A STANDARD LUER (B)(4)% TAPER. WITHOUT THE COMPLAINT BREATHING CIRCUIT WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE PROBLEM AS REPORTED BY THE CUSTOMER. ALL INFANT BREATHING CIRCUITS ARE PRESSURE AND FLOW TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 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 THAT THEY HAD AN ISSUE WITH AN RT265 INFANT BREATHING CIRCUIT KIT THAT HAD BECOME DISCONNECTED FROM THE PRESSURE LINE DURING USE WITH A LEONIE VENTILATOR. THE HOSPITAL CONFIRMED THAT FOLLOWING THE DISCONNECTION THE BABY WAS VENTILATED WITH ADDITIONAL THERAPIES, WITH NO FURTHER CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348515 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 'LEONIE' VENTILATOR