BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5618900 · Received April 29, 2016

    Report

    Report Number
    9611451-2016-00188
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Report Date
    March 30, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT #: 150813, MANUFACTURE DATE: 08/13/2015, QUANTITY AFFECTED: 1. LOT: 150916, MANUFACTURE DATE: 09/16/2015, QUANTITY AFFECTED: 2. LOT: UNKNOWN, MANUFACTURE DATE: UNKNOWN, QUANTITY AFFECTED: 12. MANUFACTURER NARRATIVE METHOD: FOURTEEN COMPLAINT RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS (ONE UNIT WITH LOT NUMBER 150813, TWO UNITS WITH LOT NUMBER 150916 AND ELEVEN UNITS WITH UNKNOWN LOT NUMBERS) WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT FOR ALL RETURNED COMPLAINT DEVICES, THE PROXIMAL CONNECTOR COLLAR ON THE EXPIRATORY LIMB WAS CRACKED. SOME OF THE UNITS HAD ALSO CRACKED ELBOW CONNECTOR COLLAR. THERE WAS NO VISIBLE DAMAGE NOTED TO ANY OF THE RETURNED TUBINGS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 150813 AND 150916. CONCLUSION: BASED ON THE NATURE OF THE CRACKING AND PREVIOUS INVESTIGATIONS INTO THIS TYPE OF FAILURE, THE CRACKING IS MOST LIKELY DUE TO THE CONNECTORS COMING INTO CONTACT WITH A CLEANING CHEMICAL, RESULTING IN ENVIRONMENTAL STRESS CRACKING. ALL RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE HOSPITAL REPORTED THAT THE DAMAGE OCCURRED DURING USE, WHICH SUGGESTS THAT THE COMPLAINT BREATHING CIRCUITS BECAME DAMAGED AFTER THE PRODUCTS WERE RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 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." THE USER INSTRUCTIONS ALSO STATE THE FOLLOWING: - "DO NOT SOAK, WASH, STERILIZE OR RESUE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS OR HAND SANITISERS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THEY FOUND A CRACK ON THE EXPIRATORY LIMB CONNECTOR ON SOME RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THEY FOUND A CRACK ON THE EXPIRATORY LIMB CONNECTOR ON SOME RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276876 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1