BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3100412 · Received May 8, 2013

    Report

    Report Number
    1416980-2013-11716
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED. A VISUAL INSPECTION WAS PERFORMED AND THE FLUID WAS OBSERVED FLOWING OUT OF THE FILL-PORT IMMEDIATELY AFTER THE FILL-PORT CAP WAS REMOVED. SUBSEQUENT EXAMINATION REVEALED THE CAUSE TO BE A WHITE PARTICLE WHICH WAS DETERMINED TO BE ACRYLIC (A COMPONENT OF THIS PRODUCT). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BACKFLOW FROM THE FILLING PORT DURING FILLING OF AN INFUSOR LV5 WITH AN UNKNOWN DRUG. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200584 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12J072

    Patients

    Seq Age Sex Outcome Treatment
    1