BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2220524 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20350
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K955622. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF AN AUTOMIX 3+3 COMPOUNDER WITH AN INOPERATIVE RED, ORANGE, AND GREEN STATION VOLUME KEYS WAS NOT CONFIRMED NOR REPRODUCED BY BAXTER PERSONNEL. VISUAL EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. AS A PRECAUTION, THE CONTROL MODULE KEYPAD WAS REPLACED DURING REFURBISHMENT. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN AUTOMIX 3+3 COMPOUNDER WITH INOPERATIVE RED, ORANGE, AND GREEN STATION VOLUME KEYS. THIS CONDITION OCCURRED DURING MANUAL PROGRAMMING IN THE PHARMACY. THIS CONDITION CAN LEAD TO INCORRECT COMPOUNDING OR INCORRECT LABELING OF COMPOUNDING MATERIAL. 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