BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2691079 · Received August 10, 2012

    Report

    Report Number
    6000001-2012-13134
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Date of Event
    March 27, 2012
    Report Date
    March 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FINDING NO DEVIATIONS, NONCONFORMANCES, FAILURES, OR REWORK THAT OCCURRED DURING MANUFACTURING. THERE WERE NOT ANY RELEASE / TESTING SPECIFICATIONS THAT WERE NOT MET DURING FIRST PASS TESTING THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    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. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. ADDITIONAL INFORMATION: BAXTER SERVICE CENTER RECEIVED THE DEVICE AND PERFORMED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE CUSTOMER REPORTED PROBLEM OF A ROTOR, WHICH WOULD NOT TURN, WAS NOT CONFIRMED NOR DUPLICATED DURING EVALUATION. THE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. 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 WHOSE ROTOR WOULD NOT TURN. 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