BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2220519 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20353
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT SERVICED BY BAXTER PRIOR TO THIS EVENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CORRECTIVE AND PREVENTATIVE ACTION (CAPA). DEVICE EVALUATION: THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE MINIMUM CONFIGURATION NOT BEING INSTALLED ON THE MOTOR CONTROL PRINTED CIRCUIT BOARD (PCB). A PIGGYBACK PCB WAS INSTALLED ON THE MOTOR CONTROL PCB TO CORRECT THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN AUTOMIX 3+3 COMPOUNDER IN WHICH THE GREEN, ORANGE, AND YELLOW STATION ROTORS MOVED SIMULTANEOUSLY. THIS CONDITION OCCURRED DURING COMPOUNDING 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. 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 - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1