BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2961368 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03753
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    August 1, 2012
    Report Date
    August 31, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF AN AUTOMIX DEVICE THAT "COMPOUNDED A WRONG COMPOSITION" WAS NOT CONFIRMED AS THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTOMIX COMPOUNDER "COMPOUNDED A WRONG COMPOSITION." THIS OCCURRED BEFORE USE. 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
    65501 COMPOUNDERS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1