BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2772143 · Received October 4, 2012

    Report

    Report Number
    1416980-2012-01528
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT. THE CAUSE WAS DETERMINED TO BE DAMAGE TO UMBILICAL CABLE. TO CORRECT THE CONDITION, THE UMBILICAL CABLE WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT. THIS DEVICE IS 510(K) EXEMPT - (B)(4). THE DEVICE'S ADDITIONAL 510K NUMBER IS K955622.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A REFURBISHED AUTOMIX 3X3 COMPOUNDER WAS FOUND TO HAVE ONE INOPERATIVE 10 FOOT .25 UMBILICAL CABLE ASSEMBLY. THIS WAS NOT REPORTED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT.

    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