BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2693886 · Received August 13, 2012

    Report

    Report Number
    6000001-2012-13161
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Date of Event
    July 20, 2012
    Report Date
    July 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Removal / Correction Number
    6000001-07/13/12-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF "ORANGE STATION ROTOR IS NOT TURNING WHEN PROGRAMMED" WAS CONFIRMED AND REPRODUCED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DUE TO A LOOSE WIRE SOLDER ON THE MOTOR FILTER PCB (PRINTED CIRCUIT BOARD) OF THE ORANGE STATION. THIS WAS RE-SOLDERED TO CORRECT THE REPORTED CONDITION.

    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. ITS ADDITIONAL 510(K) NUMBER IS K961008.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM AN INFUSION SUPERVISOR INVOLVING AN AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE ORANGE STATION ROTOR IS NOT TURNING WHEN PROGRAMMED. 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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1