BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2760936 · Received September 26, 2012

    Report

    Report Number
    1416980-2012-00769
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF "THE SMART BUTTON REFUSES TO WORK. THE START KEY IS NOT RESPONDING AFTER SWITCHING EMPTY SOURCE CONTAINER" WAS CONFIRMED AND REPRODUCED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DUE TO A DEFECTIVE GRAPHIC MEMBRANE KEYPAD PANEL. THE GRAPHIC MEMBRANE KEYPAD PANEL WAS REPLACED TO CORRECT THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE REPORTED CONDITION WAS CONFIRMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K955622.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A BUYER INVOLVING AN AUTOMIX 3+3 COMPOUNDER. ACCORDING TO THE FACILITY, THE SMART BUTTON REFUSES TO WORK. THE START KEY IS NOT RESPONDING AFTER SWITCHING EMPTY SOURCE CONTAINER. THIS OCCURRED DURING USE IN THE PHARMACY. UNIT IS BEING SWAPPED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUNDERS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1