BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER VERSO AIRWAY NEO/INFANT 20/BX

    MDR report key: 2446311 · Received February 10, 2012

    Report

    Report Number
    2050001-2012-00014
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PRELIMINARY EVALUATION WAS PERFORMED AND AS A RESULT, THE FOLLOWING STATEMENT WAS ADDED TO THE WARNING SECTION ON THE PRODUCT LABEL: "THIS DEVICE CONTAINS A DEAD-SPACE REDUCER. DO NOT USE WITH ARTIFICIAL AIRWAYS THAT CONTAIN DEAD-SPACE REDUCERS OR CONTAIN GEOMETRY THAT INTERFERES WITH THE DEAD-SPACE REDUCER." INVESTIGATION INTO THIS PROBLEM IS ONGOING, AND A FOLLOW UP WILL BE SUBMITTED UPON COMPLETION. CAREFUSION 2200 INC. POST-MARKET SURVEILLANCE WAS HISTORICALLY MANAGED BY CARDINAL HEALTH VIA A TRANSITIONAL SERVICE AGREEMENT FROM SEPTEMBER 1, 2009, THROUGH JULY 1, 2011, SINCE CAREFUSION OFFICIALLY SPUN OFF FROM CARDINAL HEALTH AS OF SEPTEMBER 1, 2009. A RETROSPECTIVE REVIEW OF ALL COMPLAINTS DURING THIS TIMEFRAME WAS CONDUCTED BY THE NEW CAREFUSION CUSTOMER ADVOCACY CLINICAL TEAM IN ACCORDANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORTABLE (MDR) IN ACCORDANCE WITH 21 CODE OF FEDERAL REGULATION (CFR) PART 803.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INFORMATION WAS FORWARDED TO THE CONTRACT MANUFACTURER FOR CSC200, AOK TOOLING. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT INFORMATION WAS NOT PROVIDED. AOK TOOLING REVIEWED SAMPLES OF THE INDIVIDUAL MATING PARTS (10) FROM INVENTORY AND INSPECTED THE DIMENSIONS. THE PARTS MET THE ENGINEERING SPECIFICATIONS; NO PROBLEMS FOUND. CAREFUSION INITIATED A HEALTH HAZARD EVALUATION (HHE) WHICH CONCLUDED "AS LOW AS REASONABLY PRACTICABLE (ALARP)" RISK LEVEL. THE REPORT WAS ESCALATED TO THE CAREFUSION AIRLIFE RESEARCH AND DEVELOPMENT TEAM. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION (CAPA (B)(4)) WAS INITIATED AS WELL AS PROJECT FILE (B)(4). THIS PROJECT HAS BEEN RESOURCED WITH A CROSS-FUNCTIONAL TEAM OF EXPERTS TO INVESTIGATE AND ELIMINATE THE ISSUE REPORTED. THE TEAM IS CURRENTLY CONDUCTING PRODUCT PERFORMANCE TESTING IN ORDER TO SELECT THE BEST POSSIBLE SOLUTION FOR OUR CUSTOMERS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO CAREFUSION THAT WHEN THEY REMOVED THE VERSO AIRWAY ADAPTER FROM THE PATIENT, THE SILICON SEAL CAME OFF AND STUCK IN THE PATIENT'S TRACHEOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER VERSO AIRWAY NEO/INFANT 20/BX CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI CAREFUSION CSC200

    Patients

    Seq Age Sex Outcome Treatment
    1