BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2683654 · Received August 6, 2012

    Report

    Report Number
    6000001-2012-13020
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 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). THIS IS A CLASS II 510(K) EXEMPT DEVICE WITH THE ADDITIONAL 510(K) OF K961008. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. (B)(4). THE CAUSE WAS DETERMINED TO BE A BENT UMBILICAL CABLE. TO CORRECT THE CONDITION, THE UMBILICAL CABLE WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, AN AUTOMIX COMPOUNDER WAS FOUND TO HAVE A BENT 10 FOOT 25 CONDUCTOR MOLDED 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 ASSOCIATION WITH THIS EVENT." NO ADDITIONAL INFORMATION IS AVAILABLE.

    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