BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2510146 · Received March 29, 2012

    Report

    Report Number
    6000001-2012-07228
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF KEYPAD FAILURE - NO RESPONSE WAS CONFIRMED. THE VISUAL EXAMINATION OF THE UNIT DID CONFIRM THE ISSUE. THE ROOT CAUSE WAS DUE TO A FAULTY MEMBRANE GRAPHICS PANEL KEYPAD. THIS IS A STAY-IN UNIT AND WILL NOT BE REPAIRED AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED 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 THE FACILITY'S TECHNICIAN INVOLVING THE AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE DEVICE'S TECHNICIAN REPORTED THAT THE KEYPAD WAS NOT WORKING PROPERLY; IT CANNOT PROGRAM ON MULTIPLE STATIONS. 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