BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT, ADULT, HEATED DUAL LIMB

    MDR report key: 6396894 · Received March 10, 2017

    Report

    Report Number
    8030673-2017-00301
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 8, 2017
    Report Date
    March 10, 2017
    Manufacturer
    CAREFUSION/BD
    Product Code
    BZE
    PMA / PMN Number
    K153234
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION/BD HAS REACHED OUT TO CUSTOMER THREE TIMES TO PROVIDE THE COMPLAINT DEVICE FOR FURTHER INVESTIGATION. A UPS LABEL WAS ALSO PROVIDED TO THE CUSTOMER EACH TIME. UNFORTUNATELY, CAREFUSION/BD HAS NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION OR THE REQUESTED ADDITIONAL INFORMATION. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FOLLOWING "RAINOUT ON THE EXPIRATORY SIDE, EXCESSIVE RAINOUT. THE VENT ¿SOUNDED LIKE MAKING POPCORN". HAD TO BAG PATIENT, HEAVY WATER SPRAY WHEN CHANGING EXPIRATORY FILTER, NEED TO CHANGE EXPIRATORY FILTER MORE OFTEN. NO PATIENT INJURY OR DEATH WAS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178103 CIRCUIT, ADULT, HEATED DUAL LIMB HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER BZE CAREFUSION/BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention