BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER HUMIDIFIER 120/CS

    MDR report key: 3296299 · Received August 19, 2013

    Report

    Report Number
    8030673-2013-00051
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BTT
    PMA / PMN Number
    K801252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS SUBMITTED FOR EVALUATION. THE SAMPLE WAS INSPECTED BY CAREFUSION QUALITY PERSONNEL AND NO ISSUES WERE OBSERVED. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF INTERNAL DEVICE HISTORY RECORDS COULD NOT BE PERFORMED TO SEARCH FOR ANY EXTRAORDINARY EVENTS THAT MIGHT HAVE LED TO THE DEFECT REPORTED. IN ADDITION, THE MANUFACTURING PROCESS WAS REVIEWED AND NO ISSUES WERE OBSERVED. THIS INCLUDES MATERIALS, DESIGN AND COMPONENTS OF THE PRODUCT. BASED ON THE INVESTIGATION RESULTS, THE MOST PROBABLE CAUSE FOR THE ISSUE REPORTED COULD NOT BE DETERMINED. DUE TO THE NATURE OF THE COMPLAINT DESCRIPTION, CAREFUSION QUALITY PERSONNEL TRIED TO REPLICATE THE ISSUE REPORTED AND OBSERVED THAT IF THE NUT OF THE PRODUCT IS NOT COMPLETELY THREADED ON THE OUTLET OF THE FLOW METER, THIS MAY CAUSE A LEAK.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY OPENED AT 002620-LOT TL 0812002. CUSTOMER REPORTED:DESPITE RUNNING OXYGEN DELIVERY, THE PATIENT COMPLAINED ABOUT RESPIRATORY TROUBLES. AFTER CHECKING THE ADAPTER THE MEDICAL STAFF IDENTIFIED, THAT OXYGEN LEAKED AT THE ADAPTER. NO OXYGEN INPUT IN THE HUMIDIFIER. TO STOP THE PATIENT SHORTNESS OF BREATH THE STAFF USED A MOBILE OXYGEN DEVICE. THE PATIENT'S NOW DISCHARGED. NO PATIENT INJURY REPORTED.  ADDITIONAL INFORMATION RECEIVED FROM INTERNATIONAL CONTACT ((B)(6) 2013: ¿THE PATIENT WAS NOT CONNECTED TO THE MOBILE OXYGEN DEVICE. THE PATIENT WAS CONNECTED TO THE CENTRAL OXYGEN SUPPLY ONLY. THE STAFF HAS RECOGNIZED THE PROBLEM BEFORE THE PATIENT WAS CONNECTED TO THE OXYGEN SUPPLY¿. FURTHER CLARIFICATION RECEIVED: THE PATIENT WAS CONNECTED THROUGH YOUR PRODUCT (CFN) TO A DEVICE FOR STATIONARY OXYGEN SUPPLY. THE DEFECTIVE PRODUCT WAS BRIEFLY USED ON THE PATIENT BUT ¿ AS THE STAFF HAS IDENTIFIED AN ISSUE RIGHT AWAY ¿ THE ERROR WAS MENTIONED IN TIME AND THE DEFECTIVE PRODUCT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401225 ADAPTER HUMIDIFIER 120/CS HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT CAREFUSION ALP2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention