BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2682884 · Received August 6, 2012

    Report

    Report Number
    6000001-2012-12998
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 18, 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
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF "STOPPING WITHOUT COMPLETE LED" 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. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS ALSO PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K961008.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A PHARMACIST INVOLVING AN AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE COMPOUNDER EXPERIENCED AN ISSUE WHERE COMPOUNDING STOPPING WITHOUT "COMPLETE LED". THIS EVENT REPORTEDLY HAPPENED ONE TIME. 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