BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2477510 · Received February 23, 2012

    Report

    Report Number
    2021710-2012-00008
    Event Type
    Other
    Date Received
    February 23, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION DID REQUEST THE RETURN OF THE USED PT CIRCUIT, GENERATOR, NASAL MASK, AND NASAL PRONGS FOR EVAL. BASED ON THE INFO PROVIDED BY THE USER FACILITY, CAREFUSION DETERMINED THAT THE USER FACILITY'S LACK OF EXPERIENCE WITH THE NEW CAREFUSION INFANT FLOW LP NCPAP SYSTEM (GENERATOR, MASK, PRONGS, BONNET AND HEADGEAR) WAS THE 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 AND THE CONDITION OF THE PT WAS COPIED FROM AN EMAIL FROM A CAREFUSION SALES CONSULTANT. "[NAME REMOVED], WHO IS THE NICU SUPERVISOR AT [FACILITY NAME REMOVED] HAS BROUGHT TO MY ATTENTION OF AN INCREASED NUMBER OF BABIES WITH SOME SEPTAL BREAKDOWN SINCE MOVING TO THE NEW LP SIPAP PRODUCTS. I WAS WONDERING IF YOU COULD LET US KNOW IF THIS IS AN ISSUE THAT YOU HAVE SEEN WITH OTHER USERS OF THE LP SYSTEM? DO YOU HAVE ANY SUGGESTIONS FOR (B)(6) AND HIS TEAM TO HELP THEM REMEDY THIS ISSUE? MY FIRST THOUGHT WAS THAT SINCE THE INTRODUCTION OF THE NEW X-SMALL SIZED PRONGS THAT WILL ALLOW THE USE OF SIPAP ON EVEN SMALLER MICRO PREMATURE BABIES, WITH THEIR SKIN INTEGRITY BEING MUCH MORE DELICATE CREATING THE POSSIBILITY OF THE SEPTAL BREAKDOWN. WHEN I ASKED (B)(6) WHAT PT POPULATION THIS WAS OCCURRING IN, HE THOUGHT IT WAS OCCURRING IN ALL SIZES, SO HOPEFULLY HE CAN CONFIRM IF THIS IS ONLY HAPPENING IN THE MICRO PREEMIE'S OR ALL POPULATION OF BABIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD CAREFUSION LP GENERATOR KIT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention