BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2655789 · Received July 6, 2012

    Report

    Report Number
    2021710-2012-00065
    Event Type
    Other
    Date Received
    July 6, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED ON A CAREFUSION FAILURE REPORT BY A CAREFUSION (B)(4) REP IN RESPONSE TO A CONVERSATION WITH A USER FACILITY. (B)(4). CAREFUSION DID NOT REQUEST THE RETURN OF THE USED PATIENT CIRCUIT, GENERATOR AND NASAL PRONGS FOR EVALUATION. THE CAREFUSION INFANT FLOW LP SERIES NCPAP SYSTEM (GENERATOR, MASK, PRONGS, BONNET AND HEADGEAR) ARE THE NEXT GENERATION OF PATIENT INTERFACE DEVICES FROM CAREFUSION. AS SUCH, THE USER FACILITY'S LACK OF EXPERIENCE WITH THESE DEVICES MAY HAVE BEEN THE UNDERLYING CAUSE OF THE REPORTED EVENT. CAREFUSION HAS INITIATED A FORMAL INVESTIGATION AS A PART OF OUR CORRECTIVE AND PREVENTATIVE ACTION SYSTEM TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO CONCERNING THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM A CAREFUSION FAILURE REPORT THAT WAS FILLED OUT BY A CAREFUSION (B)(4) REP IN RESPONSE TO A USER FACILITY REP. AGE OF HARMED PERSON: (B)(6). ERROR CODES: TREATMENT WITH IF LP HAD TO BE STOPPED. DETAILED FAILURE DESCRIPTION AND MACHINE SETTINGS: AFTER (B)(6) TREATMENT, THE PT REPORTED A BAD NASAL BREAKDOWN WITH HUGE DEFORMATION OF ONE OF THE NARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) / BZD BZD CAREFUSION NASAL MASK/PRONGS 0000346718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other