BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2680989 · Received August 3, 2012

    Report

    Report Number
    6000001-2012-12964
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Removal / Correction Number
    6000001-07/13/12-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:BAXTER SERVICE CENTER (BSC) RECEIVED THE DEVICE FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT CONFIRMED THE CUSTOMER-REPORTED FRAYED UMBILICAL CABLE. THE ROOT CAUSE OF THIS CONDITION WAS NOT DETERMINED. THE UMBILICAL CABLE 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.

    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. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN AUTOMIX 3+3/AS COMPOUNDER WHICH HAD A FRAYED UMBILICAL CABLE. THIS CONDITION OCCURRED DURING PROGRAMMING/SETUP IN THE PHARMACY. THIS CONDITION COULD LEAD TO INCORRECT COMPOUNDING OR INCORRECT LABELING OF COMPOUNDING MATERIAL. 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