BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2372853 · Received December 14, 2011

    Report

    Report Number
    6000001-2011-40789
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 29, 2011
    Report Date
    November 29, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF AN AUTOMIX 3+3/AS COMPOUNDER FOR WHICH THE CUSTOMER REPORTED UNRESPONSIVE KEYPAD WAS NOT CONFIRMED OR REPRODUCED DURING SERVICE BY BAXTER PERSONNEL. THE ROOT CAUSE WAS UNDETERMINED. SERVICE VERIFIED KEYPAD FUNCTIONALITY TEST PER PROCEDURE AND NO ISSUE WAS FOUND WITH IT. A SERVICE HISTORY REVIEW REVEALED THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "KEYPAD FAILURE - NO RESPONSE".

    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'S CONTROL MODULE KEYPAD WAS UNRESPONSIVE. THE ISSUE HAPPENED DURING COMPOUNDING IN THE PHARMACY. 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