BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 2758700 · Received September 17, 2012

    Report

    Report Number
    2021710-2012-00083
    Event Type
    Other
    Date Received
    September 17, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 9, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 AN EMAIL RECEIVED FROM THE CAREFUSION PRODUCT MANAGER AND INFO PROVIDED BY THE USER FACILITY. (B)(4). THE USER FACILITY DID NOT RETURN THE USED PT CIRCUIT, GENERATOR AND NASAL PRONGS FOR EVALUATION. BASED ON THE INFO PROVIDED BY THE USER FACILITY'S RESPIRATORY THERAPIST SUPERVISOR, 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 MOST LIKELY UNDERLYING CAUSE OF THE REPORTED EVENT. CAREFUSION HAS INITIATED A FORMAL INVESTIGATION, CONDUCTED A RISK ASSESSMENT RELATED TO THE 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 THE CARE FUSION INFANT FLOW SYSTEM PRODUCT MANAGER. "I RECEIVED A CALL FROM THE RT SUPERVISOR WHO INFORMED ME OA A (B)(6) INFANT WHO SUFFERED A SIGNIFICANT SEPTUM BREAKDOWN. I HAD THE CUSTOMER DESCRIBE EVERYTHING, IT SOUNDS LIKE THE BREAKDOWN OCCURRED TO INAPPROPRIATE SIZING AND THE CUSTOMER STRAPPING THE PRONGS DOWN WAY TOO TIGHT. THE INFANT HAD A VISIT BY THE PLASTIC SURGEON YESTERDAY. SHE STATED THEY WERE USING A XS PRONG WITH THIS INFANT AND A SMALL MASK. SHE WILL BE GETTING ALL OF THE DETAILS TO ME SO I CAN INFORM TECH SUPPORT. BOTH SHE AND THE NURSING DIRECTOR AT (B)(6) ARE UPSET ABOUT THE INFANT'S BREAKDOWN BUT DON'T FEEL THAT IT WAS DUE TO THE LP SYSTEM RATHER THAN A COUPLE OF ROUGE NURSES FAILING TO COMPLY WITH OUR SUGGESTED FIXATION TECHNIQUES."

    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