BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2758690 · Received September 17, 2012

    Report

    Report Number
    2021710-2012-00081
    Event Type
    Other
    Date Received
    September 17, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION(S) WITH A USER FACILITY REPRESENTATIVE AND AN EMAIL RECEIVED FROM THE USER FACILITY. (B)(4). THE USER FACILITY DID NOT RETURN THE USED PT 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 PT INTERFACE DEVICES FROM CAREFUSION. AS SUCH THE USER FACILITIES LACK OF EXPERIENCE WITH THESE DEVICES MAY HAVE BEEN THE UNDERLYING CAUSE OF THE REPORTED EVENT. CAREFUSION HAS INITIATED A FORMAL INVESTIGATION, CONDUCTED A RISK ASSESSMENT RELATED TO THIS ISSUE AND HAS DETERMINED THE RISK TO BE "AS LOW AS REASONABLY PRACTICABLE" (ALARP).

    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 A CAREFUSION SALES REPRESENTATIVE THAT HE RECEIVED FROM THE USER FACILITY. "HI [NAME REMOVED]. AS PER OUR DISCUSSION TODAY I WANTED TO DROP YOU A NOTE TO RELAY A RECENT EXPERIENCE WE HAVE ENCOUNTERED IN OUR NICU USING THE SIPAP LP DISPOSABLE PRODUCTS. THIS WEEK WE NOTED MILD-MODERATE TRAUMA TO A PT WHO WAS PLACED ON THE SYSTEM VIA LP MASK. DESPITE DILIGENT CARE THE PT DEVELOPED A LESION ON THE BRIDGE OF THE NOSE. IN APPEARANCE IT RESEMBLES A LACERATION OR CUT. THIS IS THE SECOND PT I HAVE SEEN WITH THIS SPECIFIC TYPE OF TRAUMA [REFERENCE MFR REPORT #2021710-2012-00082]. MORE OCCASIONALLY WE MAY NOTE SOME ERYTHEMA NEAR THE NASAL SEPTUM OR UPPER LIP BUT THE TRAUMA TO THE BRIDGE OF THE NOSE IS TROUBLESOME. I CONSIDER THE RT STAFF TO BE STRONG AND EXPERIENCED USERS OF SIPAP AND TRUST THAT THEY ARE APPLYING THE SYSTEM AS INTENDED. FINALLY, WE RARELY USE THE PRONGS AT ALL AS THEY SEEM TO BE SO VERY PLIABLE THAT THEY ACTUALLY CAN COLLAPSE COMPLETELY WITHIN THE NARE. WHEN THIS HAPPEN PRESSURE IS STILL MAINTAINED WITHIN THE CIRCUIT BUT THE PT ESSENTIALLY BECOMES FULLY OCCLUDED."

    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 Other ASKU