BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER HUMIDIFIER 120/CS

    MDR report key: 3241389 · Received July 22, 2013

    Report

    Report Number
    8030673-2013-00047
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BTT
    PMA / PMN Number
    K801252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WOULD BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) RESULTS OF INVESTIGATION: NO SAMPLE WAS AVAILABLE FOR EVALUATION. 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, INVENTORY SAMPLES OF THE NUT OF THE PRODUCT WERE INSPECTED BY OUR INCOMING INSPECTION AREA AND NO PROBLEMS WERE FOUND DURING THE THREAD TEST. IN ADDITION, HEIGHT DIMENSION WAS MEASURED AND ALL WAS FOUND WITHIN SPECIFICATION. CAREFUSION TRIED TO DUPLICATE THE DEFECT REPORTED AND CONFIRMED THAT IF THE NUT IS NOT CAREFULLY SCREWED ONTO FLOWMETER, THIS COULD CAUSE AN IMPROPER FIT. PER THE INSTRUCTIONS OF USE (IFU) OF THIS PRODUCT, YOU SHOULD SECURE THE HUMIDIFIER ADAPTER TO BOTTLE BY TURNING IN A CLOCKWISE DIRECTION UNTIL THE ADAPTER HAS BEEN COMPLETELY SEATED TO THE BOTTLE TOP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING FOLLOW UP CALL ON (B)(4): WE HAVE HAD MANY ISSUES OF DIFFICULTY IN THREADING THIS PRODUCT ONTO THE FLOWMETER. IN ONE INCIDENT (OVER A MONTH AGO), A NURSE NOTICED A PATIENT¿S SATURATION WAS DROPPING AND GRABBED THE BOTTLE TO SEE WHAT THE PROBLEM WAS AND IT FELL TO THE FLOOR. THE PRODUCT WAS NOT SCREWED ON COMPLETELY. THE PATIENT WAS ON A NASAL CANNULA AND AFTER THE PRODUCT FELL THE NURSE FULLY THREADED THE PRODUCT BACK ON THE FLOWMETER WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340511 ADAPTER HUMIDIFIER 120/CS HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT CAREFUSION ALP2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NASAL CANNULA