BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2608657 · Received May 31, 2012

    Report

    Report Number
    2021710-2012-00052
    Event Type
    Other
    Date Received
    May 31, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED AT: (B)(6). THE FOREIGN USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. (B)(4). CAREFUSION DID NOT REQUEST THE RETURN OF THE USED PATIENT CIRCUIT, GENERATOR, NASAL MASKS AND NASAL PRONGS FOR EVAL. BASED ON THE INFO PROVIDED BY THE CAREFUSION AREA SALES MGR IN (B)(4) AND THE CAREFUSION PRODUCT MGR FOR THE INFANT FLOW SYSTEM, CAREFUSION DETERMINED THAT THE USER FACILITY'S LACK OF EXPERIENCE WITH THE NEW CAREFUSION INFANT FLOW NCPAP SYSTEM (GENERATOR, MASK, PRONGS, BONNET, AND HEADGEAR) WAS THE MOST LIKELY UNDERLYING CAUSE OF THE REPORTED EVENT. CAREFUSION HAS PROVIDED THE USER FACILITY ADDITIONAL TRAINING ON THE PROPER APPLICATION TECHNIQUES.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO AN EMAIL FROM THE CAREFUSION PRODUCT MGR FOR THE INFANT FLOW SYSTEM. "(B)(6) TWO PTS USING THE INFANT FLOW LP GENERATOR (B)(4) ONE PT HAD INJURY TO NASAL BRIDGE FROM THE MASK ((B)(4) INFANT FLOW LP SMALL). THE OTHER PT HAD INJURY TO THE SEPTUM FROM THE NASAL PRONGS (SIZE NOT KNOWN). A SITE VISIT, CONFERENCE CALL AND ADDITIONAL TRAINING WERE PROVIDED AS SALES MGR AND [NAME REMOVED] FELT INJURIES COULD BE RELATED TO IMPROPER APPLICATION TECHNIQUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) / BZD BZD CAREFUSION NASAL MASK/PRONGS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASKU