BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2758699 · Received September 17, 2012

    Report

    Report Number
    2021710-2012-00082
    Event Type
    Other
    Date Received
    September 17, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 1, 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 MANUFACTURER. 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). ON (B)(4) 2012 CAREFUSION SENT AN EMAIL TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. ON (B)(6) 2012 A USER FACILITY REPRESENTATIVE RESPONDED TO THE EMAIL AND STATED IT HAD BEEN SEVERAL MONTHS SINCE THE OCCURRENCE OF THIS EVENT AND THAT HE DID NOT HAVE ANY SPECIFIC INFO ASSOCIATED TO THIS EVENT. 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 FOR 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 IS A SUMMARY OF INFO PROVIDED BY THE CUSTOMER DURING A PHONE CONVERSATION WITH A CAREFUSION TECH SUPPORT SPECIALIST. THE CUSTOMER REPORTED THEY SAW IN THE PAST A PT WITH MILD-MODERATE TRAUMA AFTER THEY WERE PLACED ON THE INFANT FLOW LP SERIES NCPAP SYSTEM. DESPITE DILIGENT CARE THE PT DEVELOPED A LESION ON THE BRIDGE OF THE NOSE WHICH RESEMBLED A LACERATION OR CUT.

    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