BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2945853 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03049
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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 K955622.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF AN AUTOMIX 3+3 COMPOUNDER WITH A MALFUNCTION OF "UNDER DELIVERY" CAUSED BY BLUE STATION ROTOR/MOTOR STOPPING OR RUNNING TOO FAST DURING DELIVERY" WAS NOT CONFIRMED OR REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A FACILITY INVOLVING AN AUTOMIX 3+3 COMPOUNDER. ACCORDING TO THE FACILITY, THEY ARE REPORTING "UNDER DELIVERY CAUSED BY BLUE STATION ROTOR/MOTOR STOPPING OR RUNNING TOO FAST DURING DELIVERY." THIS EVENT OCCURRED DURING COMPOUNDING IN THE PHARMACY. 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
    51017 COMPOUNDERS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1