BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2575378 · Received May 15, 2012

    Report

    Report Number
    6000001-2012-10517
    Event Type
    Malfunction
    Date Received
    May 15, 2012
    Date of Event
    May 21, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K955622. DEVICE EVALUATION: BAXTER (B)(4) RECEIVED THE DEVICE AND PERFORMED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE CUSTOMER REPORTED PROBLEM OF A COMPOUNDER WHICH WOULD NOT BEGIN COMPOUNDING ONCE THE START-BUTTON WAS PRESSED WAS CONFIRMED AND DUPLICATED. THIS CONDITION WAS CAUSED BY A DAMAGED KEYPAD FLEX CABLE. THE DEVICE WAS REFURBISHED BY REPLACING THE MEMBRANE GRAPHIC PANEL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN AUTOMIX 3+3 COMPOUNDER WHICH WOULD NOT BEGIN COMPOUNDING. THIS CONDITION OCCURRED UPON PRESSING START 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
    1 COMPOUNDERS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1