BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2798662 · Received October 22, 2012

    Report

    Report Number
    1416980-2012-02954
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF "KEYPAD NOT WORKING" WAS CONFIRMED AND REPRODUCED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DUE TO A FAULTY KEYPAD. HOWEVER, NO REPAIRS HAVE BEEN MADE AT THIS TIME AS THIS IS A STAY-IN DEVICE. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. 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

    THE FACILITY REPORTED AN AUTOMIX 3+3 COMPOUNDER WHERE THE KEYPAD WAS NOT WORKING. THIS CONDITION OCCURRED DURING PROGRAMMING IN THE PHARMACY. 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 - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1