BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2682950 · Received August 6, 2012

    Report

    Report Number
    6000001-2012-12999
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 5, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED PROBLEM OF THE "ORANGE STATION IS FROZEN, WILL NOT TURN" 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 DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS FOUND THAT WOULD CAUSE OR CONTRIBUTE TO 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. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A FACILITY INVOLVING AN AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE "ORANGE STATION IS FROZEN, WILL NOT TURN." THE UNIT IS BEING SWAPPED. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE THERE WAS NO PATIENT INJURY 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