BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2221557 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20521
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF OVER DELIVERY WITHOUT ALARM - MEASURED WAS NOT CONFIRMED. THE VISUAL EXAMINATION OF THE UNIT DID NOT CONFIRM THE ISSUE. THE ROOT CAUSE WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    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 OVERFILLED ON A TWO TOTAL PARENTAL NUTRITION'S (TPN) OF SEVERAL THAT WERE PERFORMED AT 2600ML. THE FIRST REPORTED WAS AN OVERFILL OF 500 ML. THE SECOND OVERFILL WAS OF 100 ML. THERE WAS NO PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT. 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 - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1