BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2654326 · Received July 5, 2012

    Report

    Report Number
    2021710-2012-00066
    Event Type
    Other
    Date Received
    July 5, 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 MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED ON A CAREFUSION FAILURE REPORT BY A CAREFUSION (B)(4) REPRESENTATIVE IN RESPONSE TO A CONVERSATION WITH A USER FACILITY REPRESENTATIVE. (B)(4). CAREFUSION DID NOT REQUEST THE RETURN OF THE USED PT CIRCUIT, GENERATOR AND NASAL PRONGS FOR EVALUATION. THE CAREFUSION INFANT FLOW LP SERIES NCPAP SYSTEM (GENERATOR, MASK, PRONGS, BONNET & HEADGEAR) ARE THE NEXT GENERATION OF PT INTERFACE DEVICES FROM CAREFUSION. AS SUCH THE USER FACILITY'S LACK OF EXPERIENCED WITH THESE DEVICE MAY HAVE BEEN THE UNDERLYING CAUSE OF THE REPORTED EVENT. CAREFUSION HAS INITIATED A FORMAL INVESTIGATION AS A PART OF OUR CORRECTIVE AND PREVENTIVE ACTION SYSTEM TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO CONCERNING THE EVENT AND THE CONDITION OF THE PATIENT WAS COPIED FROM A CAREFUSION FAILURE REPORT THAT WAS FILLED OUT BY A CAREFUSION (B)(4) REPRESENTATIVE IN RESPONSE TO A CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "FAILURE DESCRIPTION/INCIDENT REPORT: WHAT HAS HAPPENED? SEVERE SKIN INJURY OF THE PT. DATE OF OCCURRENCE: (B)(6). TIME OF OCCURRENCE: AFTER 2 WEEKS OF TREATMENT. OCCURRED DURING TESTING OR WHILE ON PT? WHILE ON PT. MALFUNCTION CAUSING PT HARM? YES, SEVERE BRUISE OF THE NOSE AND NASAL BREAKDOWN. NAME OF HARMED PERSON: NA. GENDER OF HARMED PERSON: F. AGE OF HARMED PERSON: (B)(6). ERROR CODES(-S): NCPAP HAD TO BE STOPPED. DETAILED FAILURE DESCRIPTION AND MACHINE SETTINGS: THE USE OF THE INFANT FLOW LP CAUSED A SEVERE BRUISE OF THE NOSE, BETWEEN NARES AND LIP."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ASKU