BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2710551 · Received August 22, 2012

    Report

    Report Number
    6000001-2012-13393
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    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 K961008. EVALUATION SUMMARY: BAXTER SERVICE CENTER RECEIVED THE DEVICE AND PERFORMED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE CUSTOMER REPORTED PROBLEM OF A COMPOUNDER WHICH WOULD NOT AUDIBLY ALERT UPON POWER UP OR WHEN THE COMPOUNDING JOB WAS COMPLETED WAS CONFIRMED AND DUPLICATED DURING DEVICE EVALUATION. THIS CONDITION WAS CAUSED BY A DEFECTIVE SPEAKER ON THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). THE I/O PCB WAS REPLACED TO CORRECT THE REPORTED CONDITION. THE DEVICE WAS REFURBISHED PER PROCEDURE; BSC ENSURED THAT THE UNIT MET THE REQUIRED PERFORMANCE SPECIFICATION AND CRITERIA FOR FUNCTIONALITY AND RELEASE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN AUTOMIX 3+3/AS COMPOUNDER WHICH WOULD NOT AUDIBLY ALERT UPON POWER UP OR WHEN THE COMPOUNDING JOB WAS COMPLETED. THIS CONDITION OCCURRED DURING COMPOUNDING 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 AT THIS TIME.

    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