BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2714460 · Received August 24, 2012

    Report

    Report Number
    6000001-2012-13483
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    July 31, 2012
    Report Date
    August 1, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION OF 'THE COMPOUNDER COMPLETED THE TPN AND DELIVERED 2200ML INSTEAD OF 2000ML IN FINAL BAG' WAS NOT CONFIRMED NOR REPRODUCED DURING DEVICE EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED AND NO REPAIR WAS NECESSARY TO CORRECT THE REPORTED CONDITION.A SERVICE HISTORY REVIEW WAS ALSO PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDER EVALUATION BY BAXTER PERSONNEL. 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 K961008.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A PHARMACY TECHNICIAN INVOLVING AN AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE COMPOUNDER COMPLETED THE TPN (TOTAL PARENTERAL NUTRITION) AND DELIVERED 2200ML INSTEAD OF 2000ML IN FINAL BAG. THE 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 AT THIS TIME.

    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