BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 15189371 · Received August 8, 2022

    Report

    Report Number
    9611451-2022-00729
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 8, 2022
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION B5 DESCRIBE EVENT OR PROBLEM: A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE EXPIRATORY LIMB OF A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND DAMAGED. SECTION D1 BRAND NAME: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. SECTION D2 COMMON DEVICE NAME: BZE, PRODUCT CODE: BZE. SECTION D4 MODEL #; CATALOG #: RT266; RT266. METHOD: THE COMPLAINT RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED AND ANALYZED. RESULTS: VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE EVAQUA2 TUBE WAS FOUND DEGRADED IN SEVERAL AREAS. FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED AND RESULTS SHOWED THAT THE EVAQUA2 TUBE MATERIAL HAS BEEN CHEMICALLY ATTACKED. CONCLUSION: BASED ON THE FTIR ANALYSIS, THE EVAQUA2 TUBE DEGRADED DUE TO BEING CHEMICALLY ATTACKED. ALL RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "DO NOT USE MEDICATIONS CONTAINING TYLOXAPOL (SUCH AS TACHOLIQUIN) AS THIS MAY DAMAGE THE TUBING AND LEAD TO A LOSS OF VENTILATION PRESSURE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT."

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE EXPIRATORY LIMB OF A RT330 OPTIFLOW JUNIOR TUBING KIT WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE EXPIRATORY LIMB OF A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989076 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT266 NOT PROVIDED
    2148373 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT266 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown