BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2699545 · Received August 15, 2012

    Report

    Report Number
    6000001-2012-13219
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FRAYED UMBILICAL CABLE WAS CONFIRMED. IT WAS UNKNOWN WHAT CAUSED THE DAMAGED UMBILICAL CABLE. THE UMBILICAL CABLE WAS REPLACED TO CORRECT THIS 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 WITH A FRAYED UMBILICAL CABLE. THIS CONDITION WAS NOTICED DURING PROGRAMMING 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