BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19234345 · Received May 2, 2024

    Report

    Report Number
    9611451-2024-00350
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 4, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SUBJECT RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTIONS: SECTION D1: BRAND NAME UPDATED TO FISHER & PAYKEL HEALTHCARE; SECTION D2A: COMMON DEVICE NAME UPDATED TO BREATHING CIRCUIT; SECTION D4: LOT NUMBER AND DEVICE IDENTIFICATION INFORMATION WERE NOT RECEIVED; SECTION G1: CONTACT PERSON UPDATED TO MR. (B)(4). METHOD: THE SUBJECT RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RECEIVED AT FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION, WHERE IT WAS VISUALLY INSPECTED, LEAK TESTED AND ANALYSED. RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE INSPIRATORY TUBE WAS DAMAGED. LEAK TESTING CONFIRMED THAT THE LIMB ASSEMBLY WAS OUT OF SPECIFICATION. ADDITIONAL MATERIAL ANALYSIS OF THE TUBING WAS PERFORMED. THE ANALYSIS INDICATED THAT THE TUBING HAD LIKELY UNDERGONE A CLEANING PROCEDURE. CONCLUSION: WE ARE UNABLE TO CONFIRM THE CAUSE OF THE OBSERVED LEAK, HOWEVER, IT IS POSSIBLE THAT THE TUBING HAD UNDERGONE A CLEANING PROCEDURE. 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 CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT STATE: "USE USP STERILE WATER FOR INHALATION OR EQUIVALENT FOR HUMIDIFICATION. DO NOT ADD OTHER SUBSTANCES TO THE WATER." "DO NOT USE MEDICATIONS CONTAINING TYLOXAPOL (SUCH AS TACHOLIQUIN) AS THIS MAY DAMAGE THE TUBING AND LEAD TO A LOSS OF VENTILATION PRESSURE." "DO NOT SOAK, WASH, STERILIZE OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS OR HAND SANITIZERS." "DO NOT USE BEYOND 7 DAYS MAXIMUM DURATION OF USE." "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN COLUMBUS REPORTED THAT A HISSING SOUND COMING FROM A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS OBSERVED DURING PATIENT USE. THE HEALTHCARE FACILITY LATER REPORTED THAT THE SUBJECT RT266 CIRCUIT HAD PASSED THE VENTILATOR LEAK TEST. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN COLUMBUS REPORTED THAT A HISSING SOUND COMING FROM A RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS OBSERVED DURING PATIENT USE. THE HEALTHCARE FACILITY LATER REPORTED THAT THE SUBJECT RT266 CIRCUIT HAD PASSED THE VENTILATOR LEAK TEST. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457376 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT266 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INTERSURGICAL BREATHING TUBE SUPPORT.