BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 19823785 · Received July 25, 2024

    Report

    Report Number
    9611451-2024-00540
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 6, 2024
    Report Date
    July 16, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SUBJECT RT265 INFANT BREATHING CIRCUIT HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND 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 D4: MODEL AND CATALOG # UPDATED TO RT269 SECTION D4: LOT NUMBER AND UDI DETAILS: F&P EXERCISED A GOOD FAITH EFFORT TO OBTAIN THE DEVICE IDENTIFICATION, BUT NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE FACILITY SECTION G4: THE F&P HEALTHCARE RT269 BREATHING CIRCUIT IS NOT CURRENTLY AVAILABLE FOR SALE IN THE UNITED STATES OF AMERICA (USA) BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT, THE RT265 BREATHING CIRCUIT, IS K103767 METHOD: THE SUBJECT RT269 INFANT BREATHING CIRCUIT WAS REQUESTED BUT NOT RETURNED TO F&P HEALTHCARE AS IT HAD BEEN DISCARDED BY THE HEALTHCARE FACILITY. F&P HEALTHCARE OBTAINED ADDITIONAL INFORMATION FROM THE HEALTHCARE FACILITY CONCERNING THE EVENT INCLUDING ENVIRONMENTAL CONDITIONS (I.E. ANY SOURCE OF COLD AIR OR HEAT), DEVICE SET UP, DETAILS OF THE THERAPY DELIVERED, AND LOCATION OF THE CONDENSATE TO SUPPORT OUR INVESTIGATION. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT WHEN CONDENSATE WAS BEING REMOVED FROM A RT269 INFANT BREATHING CIRCUIT, THE NEONATAL PATIENT ASPIRATED WATER AND REQUIRED RESUSCITATION. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT WAS RECEIVING INVASIVE VENTILATION AND SALINE NEBULIZERS ON NON-F&P HEALTHCARE EQUIPMENT, WITH CONDENSATION OBSERVED IN THE ENDOTRACHEAL TUBE AT THE Y PIECE AND THE CONNECTING TUBING CLOSEST TO THE PATIENT. CONCLUSION: BASED ON THE INFORMATION AVAILABLE, F&P HEALTHCARE IS UNABLE TO DETERMINE THE EXACT CAUSE OF THE CONDENSATION. CONDENSATE IN THE HUMIDIFICATION SYSTEM IS AN EXPECTED SIDE EFFECT OF HEATED PASS-OVER HUMIDIFICATION SYSTEMS IN MANY CONDITIONS AND MAY VARY BETWEEN LIGHT MISTING TO WATER DROPLETS THAT FORM ON THE WALL OF COOL BREATHING CIRCUIT TUBING. THE AMOUNT OF CONDENSATE IN THE VENTILATION SYSTEM IS INFLUENCED BY A NUMBER OF FACTORS, INCLUDING SET UP AND ENVIRONMENTAL CONDITIONS. WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE UNABLE TO DETERMINE WHETHER ANY DEVICE DEFICIENCIES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDENSATE IN THE RT269 INFANT BREATHING CIRCUIT. ALL RT269 INFANT 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 SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT269 INFANT BREATHING CIRCUIT INCLUDE A PICTORIAL SHOWING THE CORRECT SETUP TO CONNECT THE UNHEATED EXTENSION WHILE THE PATIENT IS IN AN INCUBATOR OR INFANT WARMER. IT ALSO INCLUDES THE FOLLOWING: - "APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH." - "WHEN MOUNTING A HUMIDIFIER ADJACENT TO A PATIENT ENSURE THAT THE HUMIDIFIER IS ALWAYS POSITIONED LOWER THAN THE PATIENT." - "DO NOT COVER THE CIRCUIT WITH MATERIAL SUCH AS BLANKETS, TOWELS OR BED LINEN.".

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT WHEN CONDENSATE WAS BEING REMOVED FROM A RT265 INFANT BREATHING CIRCUIT, THE NEONATAL PATIENT ASPIRATED WATER AND REQUIRED RESUSCITATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT WHEN CONDENSATE WAS BEING REMOVED FROM A FISHER & PAYKEL (F&P) HEALTHCARE RT265 INFANT BREATHING CIRCUIT, THE NEONATAL PATIENT ASPIRATED WATER AND REQUIRED RESUSCITATION. CONTRARY TO THE INITIAL REPORT, IT WAS LATER CONFIRMED THAT THE SUBJECT DEVICE IS THE F&P HEALTHCARE RT269 INFANT DUAL HEATED BREATHING CIRCUIT WITH EVAQUA 2 TECHNOLOGY AND MR290 AUTOFEED CHAMBER FOR SLE6000 VENTILATORS (RT269 INFANT BREATHING CIRCUIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356357 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT269

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Unknown Life Threatening| R AVANOS CLOSED SUCTION CATHETER.| F&P HEALTHCARE RESPIRATORY HUMIDIFIER.| NEBULISER OF UNSPECIFIED BRAND.| SLE VENTILATOR.| SMITHS MEDICAL TRACHEAL TUBE.