BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2879435 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07675
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE REPORTED CONDITION OF AN AUTOMIX COMPOUNDER WITH A KEYPAD FAILURE WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO CORROSION FOUND OF THE FLEX CABLE. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE.

    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 FACILITY INVOLVING AN AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE KEYPAD IS NOT RESPONDING TO ANY KEYPAD PRESSES ON THIS DEVICE. THIS EVENT OCCURRED DURING SETUP IN THE PHARMACY. UNIT IS BEING SWAPPED. 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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1