BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULIZER HEATER 1/CS

    MDR report key: 2446343 · Received February 10, 2012

    Report

    Report Number
    2050001-2012-00020
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 26, 2010
    Report Date
    January 26, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CAF
    PMA / PMN Number
    K780456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION WAS CONFIRMED AS THE SAMPLE RECEIVED HAD THE HEAT SHELL STUCK INSIDE THE DONUT HEATER. THE HEAT SHELL WAS REMOVED FROM THE SHELL DONUT HEATER AND WAS DIMENSIONALLY REVIEWED AND DIAMETERS WERE FOUND TO BE OUTSIDE OF SPECIFICATION. THE MANUFACTURING DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. THE MANUFACTURING PROCESS WAS REVIEWED AND NO PROBLEMS WERE FOUND RELATED WITH THE ISSUE REPORTED. THE PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 1

    DONUT HEATER MELTED TO BOTTLE; HEATER WAS VERY HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZER HEATER 1/CS NEBULIZER (DIRECT PATIENT INTERFACE) CAF CAREFUSION 2M8021 0840070167

    Patients

    Seq Age Sex Outcome Treatment
    1