BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2788655 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02379
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDI
    Removal / Correction Number
    6000001-07/13/12-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF "FRAYED UMB CABLE" WAS CONFIRMED DURING DEVICE EVALUATION. THE ROOT CAUSE WAS DUE TO PHYSICAL DAMAGE. THERE WERE NO REPAIRS PERFORMED ON THE DEVICE AS IT IS A STAY-IN UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K955622.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A FACILITY INVOLVING AN AUTOMIX 3+3 COMPOUNDER. ACCORDING TO THE FACILITY, THEY ARE REPORTING A FRAYED UMB (UMBILICAL) CABLE. UNIT IS BEING SWAPPED. 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 KDI BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1