BEUDAMED
    FDA Adverse Event Summary report: N

    HUDSON RCI AQUAPAK

    MDR report key: 2111948 · Received May 26, 2011

    Report

    Report Number
    2111948
    Date Received
    May 26, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 26, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    RN ON INTENSIVE CARE UNIT REPORTS THAT THE HUMIDIFIER ADAPTOR FOR THE AQUAPAK USED TO HUMIDIFY OXYGEN FOR NASAL CANNULAS CROSS THREADS TOO EASILY. IN HER MOST RECENT EXPERIENCE WITH THE DEVICE WHILE SETTING UP ON A PATIENT, THE ADAPTER CROSS THREADED AND WAS NOT DELIVERING OXYGEN TO THE PATIENT AT A THERAPEUTIC RATE. THE RN NOTICED THAT THE PATIENT'S OXYGEN SATURATION WAS NOT IMPROVING AND LOCATED AND FIXED THE CROSS THREAD RESTORING OXYGEN TO THE CORRECT FLOW RATE. THE RN HAS BEEN USING THE AQUAPAK FOR OVER 20 YEARS AND HAS ONLY NOTICED THE ADAPTOR EASILY CROSS THREADING IN THE PAST FEW MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RCI AQUAPAK RESPIRATORY HUMIDIFIER ADAPTOR CAF TELEFLEX MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *