BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2333422 · Received November 11, 2011

    Report

    Report Number
    6000001-2011-37197
    Event Type
    Malfunction
    Date Received
    November 11, 2011
    Date of Event
    October 24, 2011
    Report Date
    October 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE EVALUATION: THE REPORTED ISSUE OF AN AUTOMIX 3+3/AS COMPOUNDER FOR WHICH THE CUSTOMER REPORTED SF CHALLENGE KEY WOULD NOT RESPOND UNTIL ACCUSOURCE BOX WAS CLEANED WAS NOT CONFIRMED OR REPRODUCED DURING SERVICE BY BAXTER PERSONNEL. THE ROOT CAUSE WAS UNDETERMINED, THEREFORE NO REPAIRS WERE MADE TO CORRECT THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED THAT DEVICE HAS BEEN SERVICED TWO TIMES PRIOR TO THIS EVENT. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "KEYPAD FAILURE."

    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.

    Description of Event or Problem · 1

    BAXTER RECEIVED A COMPLAINT FROM A FACILITY INVOLVING THE AUTOMIX 3+3 COMPOUNDER. ACCORDING TO THE FACILITY, THE SF CHALLENGE KEY WOULD NOT RESPOND. 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