BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 2462092 · Received February 9, 2012

    Report

    Report Number
    2462092
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    January 25, 2012
    Report Date
    February 9, 2012
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD THE TOTAL PARENTERAL NUTRITION (TPN) RUNNING. THE NURSE WENT IN THE ROOM AND FOUND THE TUBING WET. IT APPEARS AS IF THERE IS A CRACK IN THE TUBING WHERE IT CONNECTS TO THE FILTER. THE TPN HAD BEEN HUNG AT A RATE OF 50 ML/HR AND THE LEAK WAS FOUND THE NEXT DAY. IV (INTRA VASCULAR) ASSESSMENTS WERE DONE AT LEAST EVERY 2 HRS WITH THE LAST ONE DONE IN LESS THAN 1 1/2 HRS BEFORE THE EVENT WAS DISCOVERED. THERE WERE NO ISSUES NOTED PRIOR TO THIS. THE TPN INFUSION WAS DISCONTINUED. A NEW ONE WAS NOT NEEDED AS THE PATIENT RECEIVES TPN FOR 20 HRS PER DAY AND INFUSION WOULD HAVE BEEN COMPLETED IN A LITTLE MORE THAN 1 HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX EXACTAMIX 1000 ML EVA CONTAINER NEP BAXA CORPORATION * 765874

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR