BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2683742 · Received August 6, 2012

    Report

    Report Number
    6000001-2012-13025
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    March 27, 2012
    Report Date
    March 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Removal / Correction Number
    6000001-07/13/12-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. 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. IT'S ADDITIONAL 510(K) NUMBER IS K961008.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION WAS CONFIRMED AND REPRODUCED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DUE A DEFECTIVE SERVO MOTOR. THE SERVO MOTOR WAS REPLACED TO RESOLVE THE REPORTED CONDITION.

    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 STATION ROTOR WAS VERY DIFFICULT TO TURN. THE UNIT IS BEING SWAPPED. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO PATIENT IMPACT OR MEDICAL INTERVENTION. NO FURTHER INFORMATION WAS 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