BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2693952 · Received August 13, 2012

    Report

    Report Number
    6000001-2012-13163
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Removal / Correction Number
    6000001-07/13/12-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION 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. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS FOUND THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K961008. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A PHARMACY TECHNICIAN INVOLVING AN AUTOMIX 3+3/AS COMPOUNDER. THE FACILITY REPORTED THAT THE UNIT FREEZES DURING COMPOUNDING. THIS HAPPENED DURING USE. THE UNIT IS BEING SWAPPED. THERE WAS NO PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT. NO 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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1