BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2591522 · Received May 30, 2012

    Report

    Report Number
    6000001-2012-11109
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). EVALUATION SUMMARY: THE REPORTED CONDITION OF "DEVICE'S AUTOCALIBRATION KEY WOULD NOT WORK" WAS NOT CONFIRMED DURING DEVICE EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED AND NO REPAIR WAS NECESSARY TO CORRECT THE REPORTED CONDITION. A SERVICE HISTORY REVIEW WAS ALSO PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS FOUND THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER RECEIVED A COMPLAINT FROM A FACILITY INVOLVING THE AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE DEVICE'S AUTOCALIBRATION KEY WOULD NOT WORK DURING SET UP. DUE TO THE INOPERATIVE AUTO CALIBRATION BUTTON THE UNIT IS BEING SWAPPED OUT. 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 - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1