BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDIFICATION CHAMBER

    MDR report key: 1066422 · Received April 18, 2008

    Report

    Report Number
    9611451-2008-00170
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    January 20, 2008
    Report Date
    February 15, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT DEVICES WERE DESTROYED BY THE HOSPITAL. INVESTIGATION PROVIDED IS FROM DISCUSSION WITH THE HOSPITAL. THE BREATHING SYSTEM CONSISTS OF A HUMIDIFICATION CHAMBER, BREATHING CIRCUIT AND NASAL CANNULA INTERFACE. THROUGH COMMUNICATION WITH THE HOSPITAL, WE WERE ABLE TO DETERMINE THAT A PRESSURE RELIEF VALVE (PRV) WAS NOT USED IN THE BREATHING SYSTEM. A PRV SHOULD BE USED WITH A NASAL CANNULA. THE CLINICIAN WAS TRYING TO USE HIGHER FLOW RATES OF > 4 L/MIN AND POSSIBLY REMOVED THE PRV TO ACHIEVE THIS. WHEN THE NASAL CANNULA BECAME KINKED OR PINCHED AS THERE WAS NO PRV IN THE BREATHING SYSTEM, THE PRESSURE BUILD UP CAUSED THE MR250 PLASTIC DOME TO EXPLODE, BEING THE WEAKEST PRESSURE POINT IN THE BREATHING SYSTEM. CONCLUSION: BASED ON THE RESPONSE PROVIDED BY THE HOSPITAL, THE FAILURE MODE REPORTED OCCURRED FROM THE HOSPITAL NOT USING A PRV IN THE BREATHING SYSTEM. THE HOSPITAL PURCHASES FISHER & PAYKEL HEALTHCARE'S BC SERIES NASAL CANNULA. THE RT329 INFANT CIRCUIT KIT IS FOR USE WITH THE BC SERIES NASAL CANNULA WHICH INCLUDES A PRV RATED UP TO 10 L/MIN. A WARNING STATEMENT "DO NOT BYPASS THE PRESSURE RELIEF VALVE AS THIS MAY CAUSE DAMAGE/INJURY" IS STATED ON THE USER INSTRUCTIONS PROVIDED WITH THE RT329 INFANT CIRCUIT KIT. THE HOSPITAL USED THE NASAL CANNULA WITHOUT A PRV CONTRARY TO OUR WARNING STATEMENT.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT DURING PT TREATMENT, THE MR250 HUMIDIFICATION CHAMBER OF A HIGH FLOW NASAL CANNULA DEVICE EXPLODED. THE CUSTOMER BELIEVES THAT THE EXPLOSION OF THE MR250 HUMIDIFICATION CHAMBER WAS DUE TO THE NASAL CANNULA BEING PINCHED. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE, LTD. MR250 070918

    Patients

    Seq Age Sex Outcome Treatment
    1