BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 11345773 · Received February 18, 2021

    Report

    Report Number
    9611451-2021-00040
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    November 6, 2020
    Report Date
    December 16, 2020
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE F&P 950 RESPIRATORY HUMIDIFIER 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 IS K110019. METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO F&P FOR EVALUATION AS THERE WAS NO REPORTED MALFUNCTION WITH THE DEVICE. THE DEVICE WAS PLACED BACK IN SERVICE AT THE HOSPITAL AFTER THE REPORTED EVENT. NO FURTHER INFORMATION REGARDING THE COMPLAINT DEVICE SUCH AS THE DEVICE LOT NUMBER AND THE DEVICE LOG WERE ABLE TO BE PROVIDED BY THE HOSPITAL. THIS INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HOSPITAL REPORTED THAT WHILE USING A F&P 950 RESPIRATORY HUMIDIFIER, THE DRYLINE AND EXPIRATORY LIMBS OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WERE INCORRECTLY CONNECTED IN REVERSE AT THE VENTILATOR END. CONCLUSION: THE REPORTED EVENT WAS DUE TO A USER ERROR WHEREBY THE DRY LINE AND EXPIRATORY LIMB WERE CONNECTED IN REVERSE AT THE VENTILATOR END. IN THIS INSTANCE, THE PATIENT CONTINUED TO RECEIVE GAS FLOW; HOWEVER, NO HUMIDITY WAS PROVIDED. RESPIRATORY HUMIDIFIERS ARE PART OF THE VENTILATION SYSTEM WHICH DELIVER MEDICAL GASES TO MECHANICALLY VENTILATED PATIENTS. AS SUCH, RESPIRATORY HUMIDIFIERS ARE REQUIRED TO COMPLY WITH THE GAS CONNECTION PORTS SPECIFIED IN THE CURRENT VENTILATOR STANDARD ISO 80601-2-12:2011 (ESSENTIAL PERFORMANCE FOR VENTILATORS). THIS STANDARD SPECIFIES BOTH GAS CONNECTION PORTS TO BE 22 MM MALE CONNECTIONS, WHICH COMPLY WITH ISO 5356-1:2015 (BEATHING CIRCUIT CONICAL CONNECTORS) FOR MEDICAL TAPERS. DUE TO THIS, THE PREVENTION OF REVERSED CONNECTIONS IS HIGHLY DEPENDENT UPON THE USER. THE RISK CONTROL APPLIED ACROSS ALL DEVICES IS BY PROVIDING STEP-BY-STEP INSTRUCTIVE DIAGRAMS OF THE CORRECT SET UP. THE USER INSTRUCTIONS THAT ACCOMPANY THE F&P 950 RESPIRATORY HUMIDIFIER BREATHING CIRCUITS PROVIDE STEP-BY-STEP INSTRUCTIVE DIAGRAMS ON THE CORRECT SET UP OF THE BREATHING CIRCUIT LIMBS. THE F&P 950 ADULT VENTILATOR CIRCUITS HAVE BEEN DESIGNED WITH AN INSPIRATORY LIMB, EXPIRATORY LIMB, AND DRYLINE THAT HAVE DIFFERENT COLOURS TO DIFFERENTIATE BETWEEN THE DIRECTION OF GAS FLOW. HOWEVER, THERE REMAINS AN ELEMENT OF USER DEPENDENCY FOR CORRECT SET UP BY COMPLYING WITH THE USER INSTRUCTIONS. THE USER INSTRUCTIONS INCLUDE THE FOLLOWING WARNINGS AND CAUTIONS: - "APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES." - "PROLONGED EXPOSURE TO REDUCED HUMIDITY WILL RESULT IN PATIENT HARM INCLUDING DECREASED MUCOCILIARY CLEARANCE" AN F&P REPRESENTATIVE HAS PROVIDED FURTHER TRAINING TO THE HOSPITAL WITH REGARDS TO CORRECT SETUP IN ACCORDANCE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A PATIENT DESATURATED DUE TO AN OBSTRUCTION IN THE ENDOTRACHEAL (ET) TUBE WHILE USING A F&P 950 RESPIRATORY HUMIDIFIER. IT WAS FURTHER CLARIFIED ON (B)(6) 2021 THAT FOLLOWING THE REPORTED DESATURATION, THE PATIENT BECAME BRADYCARDIC AND PRESENTED WITH PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST. THE PATIENT WAS MANUALLY VENTILATED WHILE THE ET TUBE WAS REPLACED. THE PATIENT RECOVERED TO A STABLE CONDITION IN FIFTEEN MINUTES. IT WAS REPORTED THAT THE DRYLINE AND EXPIRATORY LIMBS OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WERE INCORRECTLY CONNECTED IN REVERSE AT THE VENTILATOR END. THE CUSTOMER CONFIRMED THAT THE INCORRECT SETUP DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. THERE WERE NO FURTHER PATIENT CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE F&P 950 RESPIRATORY HUMIDIFIER 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 IS K110019. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION TO DETERMINE F&P'S INVOLVEMENT IN THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON THE COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A PATIENT DESATRUATED DUE TO AN OBSTRUCTION IN THE ENDOTRACHEAL (ET) TUBE WHILE USING AN F&P 950 RESPIRATORY HUMIDIFIER. IT WAS FURTHER CLARIFIED ON 21 JANUARY 2021 THAT FOLLOWING THE REPORTED DESATURATION, THE PATIENT BECAME BRADYCARDIC AND PRESENTED WITH PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST. THE PATIENT WAS MANUALLY VENTILATED WHILE THE ET TUBE WAS REPLACED. THE PATIENT RECOVERED TO A STABLE CONDITION IN FIFTEEN MINUTES. IT WAS REPORTED THAT THE DRYLINE AND EXPIRATORY LIMBS OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WERE INCORRECTLY CONNECTED IN REVERSE AT THE VENTILATOR END. THE CUSTOMER CONFIRMED THAT THE INCORRECT SETUP DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. THERE WERE NO FURTHER PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238318 RESPIRATORY HUMIDIFIER BTT BTT F&P 950

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT| 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT| DRAGER V500 VENTILATOR| DRAGER V500 VENTILATOR