BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2161330 · Received July 13, 2011

    Report

    Report Number
    6000001-2011-11736
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER REVIEW BY BAXTER PERSONNEL THERE IS NO INFORMATION TO SUGGEST THAT THIS DEVICE MALFUNCTION, OF A MALFUNCTIONING GREEN STATION ROTOR, WOULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS EXEMPT FROM HAVING A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. ITS ADDITIONAL 510(K) NUMBER IS K955622. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT THAT AN AUTOMIX 3+3 COMPOUNDER HAD A MALFUNCTIONING GREEN STATION ROTOR. THIS CONDITION OCCURRED DURING PROGRAMMING/SET-UP IN THE PHARMACY. THIS CONDITION CAN LEAD TO INCORRECT COMPOUNDING OR INCORRECT LABELING OF COMPOUNDING MATERIAL. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THE SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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