BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2482496 · Received March 1, 2012

    Report

    Report Number
    2021710-2012-00012
    Event Type
    Other
    Date Received
    March 1, 2012
    Date of Event
    January 7, 2012
    Report Date
    January 7, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION DID NOT REQUEST THE RETURN OF THE USED PT CIRCUIT, GENERATOR, NASAL MASKS AND NASAL PRONGS FOR EVAL. BASED ON THE INFO PROVIDED BY THE USER FACILITY AND THE CAREFUSION (B)(4) SENIOR MARKETING MGR, 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 INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST 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 WAS COPIED BY A CAREFUSION TECH SUPPORT SPECIALIST FROM AN E-MAIL FROM THE DISTRIBUTOR IN (B)(4) THAT HAD BEEN FORWARDED TO THE CAREFUSION TECH SUPPORT SPECIALIST BY THE CAREFUSION PRODUCT MANAGER. PT 2: 26 WK, (B)(6). PT ISSUE: SEPTAL BREAKDOWN. DAILY LOG: PT 2 PML 26 WEKEN 5/7. GEBOORTEGEWICHT: (B)(6). START DAG 17. PCL: 30 5/7. GEWICHT: (B)(6).

    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 6.5 MO Required Intervention ASKU