BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUDSON COMFORT FLO HUMIFICATION SYSTEM

    MDR report key: 2931639 · Received January 23, 2013

    Report

    Report Number
    3004365956-2013-00034
    Event Type
    Other
    Date Received
    January 23, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 11, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE PRODUCT IFU (INSTRUCTIONS FOR USE) STATES ON WARNINGS, "DO NOT ALLOW THE CIRCUIT TO REST ON THE PATIENT'S BARE SKIN" AND "ENSURE THAT ALL CONNECTIONS ARE SECURE AND ALL UNUSED PORTS ARE CAPPED". BASED ON THE INFORMATION SUPPLIED THE PRODUCT WAS USED AGAINST THE IFU WARNINGS CAUSED THE ISSUE REPORTED.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED, VIA MAUDE REVIEW, AS: "SKIN ABRASION 1.5 BY 1.25CM ON THE LEFT LATERAL THIGH JUST ABOVE THE KNEE NOTED ON THE ASSESSMENT. IT WAS DETERMINED TO BE A BURN FROM THE CIRCUIT OF THE HIGH FLOW NASAL CANNULA, (HFNC). THE TEMPERATURE PROBE ON THE HFNC HAD BECOME DETACHED AND THE TUBING HOT TO TOUCH. IT IS POSSIBLE THAT THE INFANT'S LEG WAS ON THE HFNC TUBING THAT IS 1.5CM IN WIDTH. IT IS UNKNOWN IF THE UNIT WAS ALARMING. IT IS NOT BELIEVED THAT THIS IS RELATED TO THE TC02 PROBE WHICH IS LOCATED ON HIS RIGHT LATERAL THIGH. REASSESSED TWO DAYS LATER; A BLISTER INTACT AND THE PERIPHERY WERE LESS RED. A SECOND DARK RED SPOT FOUND ON OUTER LEFT CALF CONSISTENT WITH LINE OF TUBING. OPINION IS IF THE SYSTEM DISCONNECTS; THE HEATER THINKS THAT THE GAS IS TOO COOL AND TRIES TO HEAT UP CAUSING THE TUBE TO GET HOT TO THE TOUCH CAUSING POSSIBLE INJURY TO THE INFANT'S SKIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32215 HUDSON COMFORT FLO HUMIFICATION SYSTEM HIGH FLOW NASAL CANNULA THERAPY CAT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1