BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2339788 · Received November 16, 2011

    Report

    Report Number
    6000001-2011-37910
    Event Type
    Malfunction
    Date Received
    November 16, 2011
    Date of Event
    October 28, 2011
    Report Date
    October 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE EVALUATION: THE REPORTED ISSUE OF AN AUTOMIX 3+3/AS COMPOUNDER WITH THE DEVICE UNDER DELIVERED WITHOUT ALARM WAS NOT CONFIRMED OR REPRODUCED DURING SERVICE BY BAXTER PERSONNEL. THE ROOT CAUSE WAS UNDETERMINED. NO REPAIR WAS NECESSARY TO FIX THE REPORTED CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "UNDER DELIVERY WITHOUT ALARM - MEASURED".

    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 COMPLAINT FROM A FACILITY INVOLVING THE AUTOMIX 3+3 COMPOUNDER. ACCORDING TO THE FACILITY, THE DEVICE HAD AN ACCURACY ISSUE. UNIT IS BEING SWAPPED. THERE WAS NO PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT. NO MEDICAL INTERVENTION. NO FURTHER INFORMATION WAS 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